|
Device |
intervertebral fusion device with bone graft, lumbar |
Definition |
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. |
Product Code | MAX |
Regulation Number |
888.3080
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUITY SURGICAL DEVICES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADCURA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEGIS SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALPHATEC SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ALTUS PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMPLIFY SURGICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMPLIFY SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTFX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTURA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BAAT MEDICAL PRODUCTS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAUI BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENVENUE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOGEND THERAPEUTICS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAMBER SPINE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CAMBER SPINE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARLSMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHOICESPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARIANCE, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CTL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CURITEVA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUTTING EDGE SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEGEN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DEGEN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIFUSION TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EMINENT SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENZTEC LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EXPANDING INNOVATIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXPANDING INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FIMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GBS COMMONWEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESYS SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ICOTEC AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTEGRITY IMPLANTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTEGRITY IMPLANTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INTELIVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOIMAX GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KEOS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KUROS BIOSCIENCES BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
LIFE SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MEDACTA INERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL S .A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SÀRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDTRONIC SOFAMOR DANEK, USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDYSSEY USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MET ONE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MET ONE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NANOHIVE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOVIS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO MEDICAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROSTRUCTURES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXT ORTHOSURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NGMEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
NVISION BIOMEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OC MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHEON SPINAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PAONAN BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARADIGM SPINE, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRINTERPREZZ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISM SURGICAL DESIGNS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAED M. ALI, M.D., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAED M. ALI, MD., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPUBLIC SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTOR3D |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RETROPSOAS TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
SHANGHAI IATRICAL-TI TECHNOLOGIES CO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI SANYOU MEDICAL CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGNUS MEDIZINTECHNIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILONY MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN MEDICAL (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRUM SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL ELEMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINAL STABILITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEEX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINEVISION SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEWORXX AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TDM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANS1 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VY SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WENZEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZS FAB INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|