|
Device |
intervertebral fusion device with bone graft, lumbar |
Definition |
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. |
Product Code | MAX |
Regulation Number |
888.3080
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4-WEB SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4-WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
4WEB,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACUITY SURGICAL DEVICES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADCURA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED MEDICAL TECHNOLOGIES AG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ADVANCED MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED RESEARCH MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED VERTEBRAL SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEGIS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESCULAP IMPLANT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLIANCE PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALLIANCE PARTNERS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
AMEDICA CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMEDICA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AMPLIFY SURGICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMPLIFY SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ASTURA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ATLAS SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AURORA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAAT MEDICAL PRODUCTS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAUI BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENVENUE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIEDERMANN MOTECH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BINDER BIOMEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGEND THERAPEUTICS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE (AKA EBI, LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET SPINE LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET SPINE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLUESTONE SYNERGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CAMBER SPINE TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CENTINEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTINEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CHOICE SPINE, LP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLARIANCE SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COALIGN INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
COGENT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COLIGNE, AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURITEVA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CUTTING EDGE SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
DEGEN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DEGEN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY SYNTHES SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEROYAL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIFUSION TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DOUBLE MEDICAL TECHNOLOGY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EISERTECH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ELITE SURGICAL SUPPLIES (PTY) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENZTEC LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EVOLUTION SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXPANDING INNOVATIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXPANDING INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXPANDING ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FACETLINK DBA LINKSPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GBS COMMONWEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GS MEDICAL CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HD LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUVEXEL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICOTEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICOTEC AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INFRONT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVA SPINAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
INNOVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNVOTEC SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA SPINE (INTEGRA LIFESCIENCES) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRITY IMPLANTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTEGRITY IMPLANTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELIVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERVENTIONAL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
JOHNSON & JOHNSON |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JOHNSON AND JOHNSON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOIMAX GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
K7 LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KEOS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KUROS BIOSCIENCES BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
L&K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LDR SPINE USA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LEGEND SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
LIFE SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MEDACTA INERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL S .A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL CONCEPTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL DESIGNS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDITECH ADVISORS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITECH SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDOS INTERNATIONAL SÀRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDTRONIC SOFAMOR DANEK USA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
19
|
MEDTRONIC SOFAMOR DANEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDTRONIC SOFAMOR DANEK, USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDYSSEY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDYSSEY USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MET 1 TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MET ONE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MET ONE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NANOHIVE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOVIS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEO MEDICAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROPRO SPINAL JAXX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEXT ORTHOSURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NGMEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NLT SPINE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NUVASIVE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
32
|
NVISION BIOMEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OC MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI SURGICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORBBO SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ORTHOFIX MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEUS FUSION SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OUROBOROS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OUROBOROS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHEON SPINAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PAONAN BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARADIGM SPINE, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PINNACLE SPINE GROUP, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
PIONEER SURGICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECIFIT MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRINTERPREZZ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISM SURGICAL DESIGNS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALGENIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
R TREE INNOVATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAED M. ALI, M.D., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAED M. ALI, MD., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RENOVIS SURGICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
REPUBLIC SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTOR3D |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROYAL OAK MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RTI SURGICAL, INC. DBA RTI BIOLOGICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RUBICON SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFE ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SAPPHIRE MEDICAL GROUP, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
19
|
SEASPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHANGHAI IATRICAL-TI TECHNOLOGIES CO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI SANYOU MEDICAL CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDIZINTECHNIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SILONY MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SINTEA PLUSTEK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN MEDICAL (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRUM SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL EDGE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINAL ELEMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SPINAL STABILITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE INNOVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE SMITH PARTNERS L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINE VIEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SPINEEX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SPINEMED GES.M.B.H |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
SPINEVISION S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWAY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWORKS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEWORXX AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SUMMIT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES USA PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TDM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THOMPSON MIS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIDES MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TITAN SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TRANS1 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANS1 INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRANS1, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ULRICH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VALLUM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTEBRAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
VERTERA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XENCO MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER BIOMET SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER TRABECULAR METAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZS FAB INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
4-Web Inc. |
II |
Dec-16-2014 |
2 |
Advanced Research Medical, LLC |
II |
Apr-29-2024 |
3 |
Aesculap, Inc. |
II |
Jul-25-2013 |
4 |
Alphatec Spine, Inc. |
II |
May-29-2012 |
5 |
Alphatec Spine, Inc. |
II |
Nov-12-2009 |
6 |
Amendia, Inc |
II |
Dec-20-2016 |
7 |
Biomet Spine LLC. |
II |
Dec-16-2014 |
8 |
Biomet Spine, LLC |
II |
Feb-09-2015 |
9 |
CTL Medical Corporation |
II |
Jul-04-2020 |
10 |
Captiva Spine, Inc |
II |
Jun-07-2012 |
11 |
CoreLink LLC |
II |
Jan-12-2023 |
12 |
DePuy Orthopaedics, Inc. |
II |
Mar-02-2018 |
13 |
DePuy Spine, Inc. |
II |
Jul-01-2022 |
14 |
DePuy Spine, Inc. |
II |
Apr-27-2019 |
15 |
Ebi, Llc |
II |
Sep-27-2013 |
16 |
Genesys Orthopedic Systems, LLC |
II |
Jun-01-2012 |
17 |
Globus Medical, Inc. |
II |
Aug-22-2020 |
18 |
Howmedica Osteonics Corp. |
II |
Dec-13-2018 |
19 |
Howmedica Osteonics Corp. |
II |
Sep-12-2016 |
20 |
Innovasis, Inc |
II |
Sep-17-2024 |
21 |
Integrity Implants Inc. |
II |
Nov-07-2018 |
22 |
Interventional Spine Inc |
II |
Jan-03-2017 |
23 |
K2M, Inc |
II |
Jun-01-2021 |
24 |
Kiscomedica S.A. |
II |
Feb-27-2017 |
25 |
Medacta Usa |
II |
Nov-18-2014 |
26 |
Medicrea International |
II |
Aug-24-2023 |
27 |
Medicrea International |
II |
Feb-12-2020 |
28 |
Medtronic Sofamor Danek USA Inc |
II |
Jul-24-2009 |
29 |
Medtronic Sofamor Danek USA, Inc |
II |
Apr-20-2021 |
30 |
Neuropro Spinal Jaxx |
II |
Apr-10-2018 |
31 |
Orthofix, Inc. |
II |
Feb-15-2012 |
32 |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
II |
Jun-26-2015 |
33 |
SPINEART SA |
III |
Nov-22-2019 |
34 |
Spinal Elements |
II |
May-23-2018 |
35 |
Spinal Elements, Inc |
II |
Jan-05-2015 |
36 |
Spinal Solutions, LLC |
II |
May-27-2013 |
37 |
Spinal Solutions, LLC |
II |
Apr-22-2013 |
38 |
Spine Smith Holdings, LLC |
II |
Sep-19-2013 |
39 |
Spine Smith Partners LP |
II |
Mar-10-2013 |
40 |
Spine Wave, Inc. |
II |
Sep-11-2013 |
41 |
SpineFrontier, Inc. |
II |
May-07-2014 |
42 |
SpineFrontier, Inc. |
II |
Nov-21-2012 |
43 |
Stryker Spine |
II |
Apr-20-2021 |
44 |
Stryker Spine |
II |
Oct-10-2018 |
45 |
Stryker Spine |
II |
Feb-23-2016 |
46 |
Synthes (USA) Products LLC |
II |
Apr-14-2016 |
47 |
Synthes Spine |
II |
Jan-30-2009 |
48 |
Synthes USA (HQ), Inc. |
II |
Nov-04-2011 |
49 |
X Spine Systems Inc |
II |
Oct-18-2016 |
50 |
XTANT MEDICAL INC |
II |
Jan-30-2019 |
51 |
Zimmer Biomet Spine, Inc |
II |
Mar-28-2017 |
52 |
Zimmer Biomet Spine, Inc |
II |
Aug-11-2016 |
53 |
Zimmer Trabecular Metal Technology, Inc. |
III |
May-10-2017 |
54 |
Zimmer, Inc. |
II |
Jan-09-2013 |
55 |
Zimmer, Inc. |
I |
Dec-22-2012 |
|
|
|
|