|
Device |
orthosis, spondylolisthesis spinal fixation |
Product Code | MNH |
Regulation Number |
888.3070
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AAXTER CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLEZ SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLURE SPINE L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APOLLO SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BM KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANWELL MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU DINGJIAN MEDICAL APPLIANCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIN BONE TECHNIQUE CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CO-LIGNE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVEREST SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K122814 GALLEON PEDICLE SCREW SYSTEM
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GOLD STANDARD ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNG CHUN BIO-S CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANOVA CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE SURGICAL DESIGNS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KALITEC DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KOREA BONE BANK CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYUNGWON MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LSK BIOPARTNERS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAZOR SURGICAL TECHNOLOGIES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDYSSEY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEUS FUSION SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTIS BIOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARADIGM SPINE, LLC |
|
SE - WITH LIMITATIONS
|
1
|
PIONEER SURGICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPUBLIC SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANACOR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINTEA PLUSTEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL EDGE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINECRAFT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SPINEVISION, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
U & I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
U&I CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULRICH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALOREM SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|