Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K932519 |
Device Name |
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM |
Applicant |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
ROBERT A KOCH |
Correspondent |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
ROBERT A KOCH |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 05/25/1993 |
Decision Date | 03/10/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|