|
Device |
intervertebral fusion device with integrated fixation, lumbar |
Definition |
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. |
Product Code | OVD |
Regulation Number |
888.3080
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUITY SURGICAL DEVICES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESCULAP IMPLANT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALPHATEC SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APOLLO SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASTURA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURORA SPINE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXIS SPINE TECHNOLOGIES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BINDER BIOMEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET SPINE & BONE HEALING TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CARLSMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTINEL SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTINEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLARIANCE, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVOLUTION SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FBC DEVICE APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FRONTIER MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HD LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INCITE INNOVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LANX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LDR SPINE USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROSTRUCTURES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVAPPROACH SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
OMNIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEUS FUSION SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSTEO VASIVE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRO SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RENOVIS SURGICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIATS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN MEDICAL (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINE SMITH PARTNERS L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SPINEART SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THEKEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TITAN SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TITAN SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VGI, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER BIOMET SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER BIOMET SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|