|
Device |
appliance, fixation, spinal intervertebral body |
Product Code | KWQ |
Regulation Number |
888.3060
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A JOHNSON & JOHNSON COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AEGIS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALLIANCE PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALPHATEC SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AMENDIA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APOLLO SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARCHIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTFX MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURORA SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXIS ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BACKROADS CONSULTING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE (AKA EBI, LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLACKSTONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDO MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CHOICESPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORE-NEXUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURITEVA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CUSTOM SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGEN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEGEN MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EFFORTMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EISERTECH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ELITE SURGICAL SUPPLIES (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EMINENT SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVOLUTION SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EVOLUTION SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G SURGICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GBS COMMONWEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GLOBUS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GLOBUS MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GOLD STANDARD ORTHOPEDICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUVEXEL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ICOTEC AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INDIUS MEDICAL TECHNOLOGIES PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTELLIGENT IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEIL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K&J CONSULTING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K2M INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K2M, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
KAHTNU SURGICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KYOCERA MEDICAL TECHNOLOGIES, INC. (KMTI) |
|
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
|
3
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LDR SPINE USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL DESIGN LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL DESIGNS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL S.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITECH SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC SOFAMOR DANEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDYNUS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDYSSEY USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MET ONE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIKRON MAKINA SANAYI VE TICARET LTD. STI. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NANOVIS SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEUROSTRUCTURES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUTECH SPINE AND BIOLOGICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
NVISION BIOMEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OAK TREE ENGINEERING, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OMNI SURGICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORBBO SURGICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOFIX US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPAEDIC & SPINE DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEUS FUSION SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED IMPLANTES, LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PIONEER SURGICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC., |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PRECISION SURGERY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRISM SURGICAL DESIGN PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALGENIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RENOVIS SURGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RSB SPINE LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAPPHIRE MEDICAL GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENT'X USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SEASPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI SANYOU MEDICAL CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SINTEA PLUSTEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN MEDICAL (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL SIMPLICITY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE 360 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINECRAFT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINENET LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWAY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SYNTHES (USA), LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TDM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANS1 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANS1 INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRANSCORP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U & I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ULRICH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ULRICH MEDICAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULRICH MEDICAL USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALORUS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTICOR, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZAVATION MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER BIOMET SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Aesculap Implant Systems |
II |
Apr-25-2012 |
2 |
Alliance Partners LLC |
II |
Jul-07-2015 |
3 |
Alphatec Spine, Inc. |
II |
Jun-07-2021 |
4 |
Alphatec Spine, Inc. |
II |
Apr-29-2015 |
5 |
Alphatec Spine, Inc. |
II |
Aug-27-2012 |
6 |
Alphatec Spine, Inc. |
II |
Jun-02-2010 |
7 |
Amendia, Inc |
II |
Dec-22-2016 |
8 |
Amendia, Inc dba Spinal Elements |
II |
Dec-13-2017 |
9 |
Biomet Spine, LLC |
II |
Nov-03-2015 |
10 |
Biomet Spine, LLC |
II |
Sep-09-2015 |
11 |
Blackstone Medical, Inc. |
II |
May-26-2010 |
12 |
Captiva Spine, Inc |
II |
May-23-2012 |
13 |
Captiva Spine, Inc |
II |
May-14-2012 |
14 |
DePuy Spine, Inc. |
II |
Nov-19-2016 |
15 |
DePuy Spine, Inc. |
II |
Dec-21-2015 |
16 |
Exactech, Inc. |
II |
Jul-14-2015 |
17 |
Genesys Orthopedic Systems, LLC |
II |
Mar-08-2013 |
18 |
Innovasis, Inc |
II |
May-20-2020 |
19 |
Innovasis, Inc |
II |
May-23-2017 |
20 |
Integra LifeSciences Corp. |
II |
May-13-2011 |
21 |
Medtronic Sofamor Danek USA Inc |
II |
May-08-2018 |
22 |
Medtronic Sofamor Danek USA Inc |
II |
Oct-10-2012 |
23 |
Medtronic Sofamor Danek USA Inc |
II |
Jan-11-2012 |
24 |
Orthofix, Inc |
II |
Feb-25-2014 |
25 |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
II |
Mar-11-2021 |
26 |
SPINEART SA |
II |
Jan-13-2018 |
27 |
Spinal Solutions, LLC |
II |
May-27-2013 |
28 |
SpineFrontier, Inc. |
II |
Dec-26-2013 |
29 |
Stryker Spine |
II |
Apr-12-2010 |
30 |
Stryker Spine |
II |
Nov-24-2009 |
31 |
Stryker Spine |
II |
Aug-20-2009 |
32 |
Synthes (USA) Products LLC |
II |
Apr-20-2016 |
33 |
Synthes USA HQ, Inc. |
II |
Feb-04-2013 |
34 |
Synthes, Inc. |
II |
Sep-22-2014 |
35 |
Theken Spine Llc |
II |
Oct-19-2010 |
36 |
Ulrich Medical USA Inc |
II |
Apr-26-2017 |
37 |
Zimmer Biomet Spine Inc. |
II |
Feb-22-2019 |
38 |
Zimmer Inc. |
II |
Dec-10-2010 |
39 |
Zimmer, Inc. |
II |
Nov-18-2013 |
|
|
|
|