|
Device |
rod, fixation, intramedullary and accessories |
Product Code | HSB |
Regulation Number |
888.3020
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADAPTABLE ORTHO INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAAT MEDICAL PRODUCTS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONVENTUS ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FH INDUSTRIE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOW-FX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GPC MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I.T.S. GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOSYS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRAUMA S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOORTHO PRODUTOS ORTOPÉDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPEDIATRICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOXEL DAC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PEGA MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
1. K200880 T2 Tibial Nailing System, T2 Femoral Nail System, ...
|
2. K203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha ...
|
3. K213328 Gamma4 System, Gamma3 System, IMN Screws System, T ...
|
4. K222309 Gamma4 System
|
5. K230512 Gamma4 System
|
STRYKER TRAUMA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SYNTEC SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORNIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WITTENSTEIN INTENS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-BOLT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|