Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K955731 |
Device Name |
OSTEONICS SHOULDER HUMERAL COMPONENTS |
Applicant |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
TERY JAROSZ |
Correspondent |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
TERY JAROSZ |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/18/1995 |
Decision Date | 03/05/1996 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|