Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
More FDA Info for this Device |
510(K) Number |
K970284 |
Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Applicant |
TURNKEY INTERGRATION USA, INC.
962 S. TAMIAMI TRAIL SUITE 203
SARASOTA, FL 34326 US
Other 510(k) Applications for this Company
|
Regulation Number |
888.3390
More FDA Info for this Regulation Number |
Classification Product Code |
KWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/24/1997 |
Decision Date |
04/21/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|