Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K850840 |
Device Name |
HOWMEDICA THREADED ACETABULAR COMPONENT |
Applicant |
PFIZER, INC. |
235 E 42ND ST. |
NY,
NY
10017
|
|
Applicant Contact |
RONALD DUCHENE |
Correspondent |
PFIZER, INC. |
235 E 42ND ST. |
NY,
NY
10017
|
|
Correspondent Contact |
RONALD DUCHENE |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 03/01/1985 |
Decision Date | 07/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|