|
Device |
intervertebral fusion device with integrated fixation, cervical |
Regulation Description |
Intervertebral body fusion device. |
Definition |
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. |
Product Code | OVE |
Regulation Number |
888.3080
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADDITIVE IMPLANTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BESPOKE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUSTONE SYNERGY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CHOICESPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLARIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIO MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDISONINNO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVOLUTION SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GS MEDICAL CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INNOSYS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICREA INTERNATIONAL S. A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOHIVE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRO SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAGICO VA USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN MEDICAL (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEUP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|