|
Device |
system, facet screw spinal device |
Product Code | MRW |
Device Class |
Unclassified
|
Premarket Reviews |
Manufacturer | Decision |
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AMENDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
APOLLO SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICE SPINE, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUSTOM SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FACET-LINK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUVEXEL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERVENTIONAL SPINE, INC. |
|
SE - WITH LIMITATIONS
|
1
|
K&J CONSULTING CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SPINE LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROVIDENCE MEDICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SC MEDICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRUM SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYGOFIX LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|