Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
More FDA Info for this Device |
510(K) Number |
K971523 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Applicant |
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
Other 510(k) Applications for this Company
|
Contact |
SAM MIRZA
Other 510(k) Applications for this Contact |
Regulation Number |
888.3353
More FDA Info for this Regulation Number |
Classification Product Code |
MEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/28/1997 |
Decision Date |
10/01/1997 |
Decision |
SN - Substantially Equivalent for Some Indications |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
|
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|