Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K871347 |
Device Name |
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS |
Applicant |
PROTEK, INC. |
5780 WEST 71ST ST. |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
KENNETH EPLING |
Correspondent |
PROTEK, INC. |
5780 WEST 71ST ST. |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
KENNETH EPLING |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 04/06/1987 |
Decision Date | 07/01/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|