| Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
More FDA Info for this Device |
| 510(K) Number |
K141972 |
| Device Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Applicant |
TOTAL JOINT ORTHOPEDICS, INC.
1567 E. Stratford Avenue
Salt Lake City, UT 84106 US
Other 510(k) Applications for this Company
|
| Contact |
CHRIS WEABER
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3358
More FDA Info for this Regulation Number |
| Classification Product Code |
OQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
07/21/2014 |
| Decision Date |
10/09/2014 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
OR - Orthopedic |
| Review Advisory Committee |
OR - Orthopedic |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|