Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
More FDA Info for this Device |
510(K) Number |
K191297 |
Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Applicant |
Theken Companies, LLC
1800 Triplett Blvd
Akron, OH 44306 US
Other 510(k) Applications for this Company
|
Contact |
Garrett Spurgeon
Other 510(k) Applications for this Contact |
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 |
05/14/2019 |
Decision Date |
09/17/2019 |
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 |
|