Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
More FDA Info for this Device |
510(K) Number |
K013676 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Applicant |
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
Other 510(k) Applications for this Company
|
Contact |
JENNIFER A DAUDELIN
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 |
11/07/2001 |
Decision Date |
12/05/2001 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|