| Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
More FDA Info for this Device |
| 510(K) Number |
K150855 |
| Device Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
| Applicant |
Limacorporate S.P.A.
Via Nazionale, 52
Villanova di San Daniele 33038 IT
Other 510(k) Applications for this Company
|
| Contact |
Sara Viel
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 |
03/31/2015 |
| Decision Date |
10/21/2015 |
| 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 |
|