Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K973837 |
Device Name |
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL |
Applicant |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
SHAVAWN EVANS PARDUHN |
Correspondent |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
SHAVAWN EVANS PARDUHN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 10/08/1997 |
Decision Date | 01/06/1998 |
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
|
|
|