|
Device |
filler, bone void, calcium compound |
Product Code | MQV |
Regulation Number |
888.3045
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACRO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AGNOVOS HEALTHCARE USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANIKA THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANIKA THERAPEUTICS. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTOSS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAXTER HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
BIOCOMPOSITES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOSTONE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOVENTUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONALIVE BIOMATERIALS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONE SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BONESUPPORT AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CELLUMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLLAGEN MATRIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONVERG ENGINEERING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURASAN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIMENSIONAL BIOCERAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIMENSIONAL BIOCERAMICS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DSM BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELUTE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ETEX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEISTLICH PHARMA AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANS BIOMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INION OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KUROS BIOSCIENCES B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KUROS BIOSCIENCES BV |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LINACOL MUH DAN KIM CEV TEK MED ITH IHR SAN VE TIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOCON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEONOVUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROSIDYAN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SEASPINE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIRAKOSS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNERGY BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNERGY BIOMEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTRIS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILTROM CORPORATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER BIOMET SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER KNEE CREATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|