|
Device |
rod, fixation, intramedullary and accessories |
Regulation Description |
Intramedullary fixation rod. |
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
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAAT MEDICAL PRODUCTS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVENTUS ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY SYNTHES |
|
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
|
7
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. (ODI-NA) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOXEL DAC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PEGA MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER TRAUMA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTEC SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TDM CO., LTD. |
|
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
|
1
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|