|
Device |
washer, bolt nut |
Product Code | HTN |
Regulation Number |
888.3030
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACUMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AKROS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ARTHROSURFACE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHROSURFACE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOPRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CC-INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORACOID SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CYCLA ORTHOPEDICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DALLEN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GLOBUS MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GM DOS REIS INDUSTRIA E COMERCIO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRATEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSHAPE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORTISE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOHELIX SURGICAL DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHER ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH AND NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGICRAFT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XIROS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|