|
Device |
posterior cervical screw system |
Regulation Description |
Posterior cervical screw system. |
Definition |
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. |
Product Code | NKG |
Regulation Number |
888.3075
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AESCULAP IMPLANT SYSTEMS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K&J CONSULTING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDICREA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSSEUS FUSION SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILONY MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL SIMPLICITY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULRICH MEDICAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZAVATION MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|