|
Device |
thoracolumbosacral pedicle screw system |
Definition |
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion. |
Product Code | NKB |
Regulation Number |
888.3070
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AESCULAP IMPLANT SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AESCULAP IMPLANT SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESCULAP IMPLANT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALLEZ SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALPHATEC SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ALTUS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMEDICA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ARTFX MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHRO-DIF |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ATLAS SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AUXEIN MEDICAL PRIVATE LIMITED/71164 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXIS ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B2B SPINE PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BACK 2 BASICS DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BAUI BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BAXANO SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENVENUE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIEDERMANN MOTECH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMET SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMET SPINE (AKA EBI, LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOMET SPINE (EBI LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE LLC, |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH, CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLACK BOX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLACK BOX MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLACKSTONE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLACKSTONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BM KOREA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CALVARY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
CARBOFIX ORTHOPEDICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CG BIO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIRAL SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CHOICE SPINE LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CLARIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CLARIANCE SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLARIANCE, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEARVIEW ORTHOPEDIC DEVELOPMENT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLIGNE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUMTOM SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGEN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
|
SE - WITH LIMITATIONS
|
1
|
DEPUY SPINE,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EBI, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EISERTECH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVOLUTION SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXPANDING ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FACETLINK DBA LINKSPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G SURGICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GBS COMMONWEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GETSET SURGICAL, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
|
SE - WITH LIMITATIONS
|
2
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GM DOS REIS INDUSTRIA E COMERICO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GPC MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAFTON MEDICAL ALLIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOGAN LOVELLS US LLP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUVEXEL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICOTEC AG |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IMPLANET |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANET S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANET, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INDIUS MEDICAL TECHNOLOGIES PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INGENIUM SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INNOSYS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INNOVATIVE SURGICAL DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
INTEGRITY IMPLANTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTEGRITY IMPLANTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELIVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELLIGENT IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JMT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JMT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHNSON & JOHNSON |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JOIMAX GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K&J CONSULTING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K2M, INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
K2M, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K2M, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
LANTERNA MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
LANX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LDR SPINE USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LIFE SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
LIFE SPINE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LINKSPINE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAHE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDICREA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL S.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDICREA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDOS INTERNATIONAL SÀRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDOS-INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC SOFAMOR DANCK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SE - WITH LIMITATIONS
|
1
|
MEDTRONIC SOFAMOR DANEK |
|
SE - WITH LIMITATIONS
|
4
|
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDTRONIC SOFAMOR DANEK USA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
SE - WITH LIMITATIONS
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SE - WITH LIMITATIONS
|
7
|
|
SUBSTANTIALLY EQUIVALENT
|
27
|
MEDTRONIC SOFAMOR DANEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
SE - WITH LIMITATIONS
|
5
|
MEDYNUS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDYSSEY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDYSSEY USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MET ONE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NANOVIS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOVIS SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOVIS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO MEDICAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXT ORTHOSURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NUVASIVE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORBBO SURGICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORION BIOTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOCIRCLE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ORTHOPEASIA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS, CORP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSSEUS FUSION SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSO SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOCENTRIC TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHEON SPINAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAONAN BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARADIGM SPINE, LLC |
|
SE - WITH LIMITATIONS
|
3
|
PHAMEDICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHYGEN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
PINNACLE SPINE GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PIONEER SURGICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PREMIA SPINE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PRESIDIO SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALGENIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
R&D INNOVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPUBLIC SPINE, L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPUBLIC SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RIVARP MEDICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROYAL OAK MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S H PITKAR ORTHOTOOLS PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S. M. A. I. O |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.M.A.I.O |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
S.M.A.I.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFE ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SAGICO VA USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
SEASPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SENECKA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEOHANCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGDONG KANGSHENG MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI SANYOU MEDICAL CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILONY MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL COPANY INDIA PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPARTEK MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL BALANCE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL BALANCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL ELEMENTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SPINAL RESOURCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINE SMITH HOLDINGS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SPINEART SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINECRAFT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINECRAFT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEOLOGY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINESELECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWAY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEWAY S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWAY SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWELDING AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP |
|
SE - WITH LIMITATIONS
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
|
SE - WITH LIMITATIONS
|
1
|
SURGALIGN SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTEC SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SYNTHES SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SYNTHES USA PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAEYEON MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TDM CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TESLAKE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE SKELETAL DESIGN PARTNERSHIP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THEKEN SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TI-TAMED (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORREY SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULRICH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SE - WITH LIMITATIONS
|
1
|
ULRICH MEDICAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VALORUS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WILTROM CORPORATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XTANT MEDICAL HOLDINGS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Z-MEDICAL GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER BIOMET SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER BIOMET SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Aesculap Implant Systems LLC |
II |
Aug-26-2022 |
2 |
Aesculap Implant Systems LLC |
II |
Jul-21-2022 |
3 |
Aesculap Implant Systems LLC |
II |
Sep-07-2012 |
4 |
Alphatec Spine, Inc. |
II |
Jun-06-2017 |
5 |
Alphatec Spine, Inc. |
II |
Nov-16-2016 |
6 |
Alphatec Spine, Inc. |
II |
Jul-22-2014 |
7 |
Alphatec Spine, Inc. |
II |
Aug-27-2013 |
8 |
Alphatec Spine, Inc. |
II |
May-28-2013 |
9 |
Amendia, Inc |
II |
Jan-10-2018 |
10 |
Atlas Spine, Inc. |
II |
Aug-27-2012 |
11 |
Back 2 Basics Direct LLC |
II |
Aug-21-2018 |
12 |
Biomet Spine, LLC |
II |
Jul-20-2015 |
13 |
Biomet Spine, LLC |
II |
Feb-24-2015 |
14 |
Biomet Spine, LLC |
II |
Feb-11-2015 |
15 |
CTL Medical Corporation |
II |
Mar-20-2019 |
16 |
Clariance Inc |
III |
Jul-18-2019 |
17 |
Custom Spine, Inc. |
II |
Jul-29-2013 |
18 |
DePuy Spine, Inc. |
II |
May-26-2015 |
19 |
DePuy Spine, Inc. |
II |
Jan-24-2013 |
20 |
Ebi, Llc |
II |
Jan-05-2015 |
21 |
Ebi, Llc |
II |
Oct-22-2010 |
22 |
Genesys Orthopedics Systems, LLC |
II |
Sep-22-2014 |
23 |
Howmedica Osteonics Corp. |
II |
Aug-05-2019 |
24 |
Icotec Ag |
II |
Dec-19-2022 |
25 |
Innovasis, Inc |
II |
Feb-20-2018 |
26 |
Innovasis, Inc |
II |
Jan-19-2016 |
27 |
Innovasis, Inc |
II |
Jul-16-2014 |
28 |
Integra LifeSciences Corp. |
II |
Aug-11-2014 |
29 |
Integra LifeSciences Corp. |
II |
Jul-01-2014 |
30 |
Integra LifeSciences Corp. |
II |
Feb-07-2014 |
31 |
Integrity Implants Inc. |
II |
Dec-05-2022 |
32 |
Integrity Implants Inc. |
II |
Dec-05-2022 |
33 |
Medicrea International |
II |
Mar-02-2020 |
34 |
Medicrea International |
II |
Dec-30-2019 |
35 |
Medtronic Sofamor Danek USA Inc |
II |
Aug-03-2018 |
36 |
Medtronic Sofamor Danek USA Inc |
II |
Jul-25-2011 |
37 |
NuVasive Inc |
II |
Nov-19-2012 |
38 |
OrthoPediatrics Corp |
II |
Jul-30-2020 |
39 |
OrthoPediatrics Corp |
II |
Jan-08-2016 |
40 |
Orthofix Inc |
II |
Mar-16-2011 |
41 |
Orthofix Inc |
II |
Mar-08-2011 |
42 |
Orthofix, Inc |
II |
Aug-18-2017 |
43 |
Orthofix, Inc |
II |
Jun-10-2015 |
44 |
Orthofix, Inc. |
II |
Sep-07-2011 |
45 |
PIONEER SURGICAL TECHNOLOGY, INC. |
II |
Sep-09-2014 |
46 |
SAFE ORTHOPAEDICS LLC |
II |
Aug-24-2022 |
47 |
SEASPINE ORTHOPEDICS CORPORATION |
II |
Apr-23-2024 |
48 |
SEASPINE ORTHOPEDICS CORPORATION |
II |
Apr-22-2024 |
49 |
SPINEART SA |
II |
May-03-2024 |
50 |
SPINEART SA |
II |
Jun-28-2021 |
51 |
SeaSpine Inc |
II |
Jun-20-2014 |
52 |
Spinal Elements, Inc |
III |
May-11-2015 |
53 |
Spinal Elements, Inc |
III |
May-07-2013 |
54 |
Stryker Spine |
II |
Nov-12-2015 |
55 |
Stryker Spine |
II |
Jun-05-2012 |
56 |
Stryker Spine |
II |
Feb-24-2010 |
57 |
Stryker Spine |
II |
Jun-26-2009 |
58 |
Synthes (USA) Products LLC |
I |
Nov-26-2014 |
59 |
Synthes USA (HQ), Inc. |
II |
Sep-15-2011 |
60 |
Synthes USA HQ, Inc. |
II |
Nov-26-2013 |
61 |
Synthes USA HQ, Inc. |
II |
Oct-01-2012 |
62 |
U&I CORP. |
II |
Jul-20-2020 |
63 |
XTANT Medical Holdings, Inc |
II |
Jan-29-2024 |
64 |
Zimmer Biomet Spine Inc. |
II |
Jan-04-2024 |
65 |
Zimmer Biomet Spine Inc. |
II |
Feb-22-2019 |
66 |
Zimmer Biomet, Inc. |
II |
Dec-15-2020 |
67 |
Zimmer Biomet, Inc. |
II |
Jun-02-2020 |
68 |
Zimmer Inc. |
II |
Oct-18-2010 |
69 |
Zimmer Inc. |
II |
Dec-22-2009 |
70 |
Zimmer Spine, Inc. |
II |
Mar-18-2016 |
71 |
Zimmer, Inc. |
II |
Jul-10-2012 |
72 |
Zimmer, Inc. |
II |
Jul-03-2012 |
|
|
|
|