| Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
More FDA Info for this Device |
| 510(K) Number |
K123434 |
| Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
|
| Contact |
DAVID FITCH
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3353
More FDA Info for this Regulation Number |
| Classification Product Code |
LZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
11/07/2012 |
| Decision Date |
02/05/2013 |
| 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 |
|