|
Device |
intervertebral fusion device with integrated fixation, lumbar |
Regulation Description |
Intervertebral body fusion device. |
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 |
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
BIOGENNIX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
BIOMET |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
CAMBER SPINE/MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
CENTINEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3 |
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
FBC DEVICE APS |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
FLEXTRONICS INTERNATIONAL USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
FRONTIER MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
GLOBUS |
|
SUBSTANTIALLY EQUIVALENT
|
5 |
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
K2M |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
LDR SPINE USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
LDR SPINE USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
NEUROSTRUCTURES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
5 |
ORTHOFIX |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
OSTEO VASIVE LLC |
|
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 |
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
SIATS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
2 |
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4 |
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4 |
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3 |
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3 |
SURGICAL INSTRUMENT MANUFACTURERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
TITAN SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
X-SPINE SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
XTANT MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
ZIMMER BIOMET SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1 |
|
|
|
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