Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device |
510(K) Number |
K213701 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Applicant |
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 US
Other 510(k) Applications for this Company
|
Contact |
Lin Song
Other 510(k) Applications for this Contact |
Regulation Number |
888.3350
More FDA Info for this Regulation Number |
Classification Product Code |
JDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/24/2021 |
Decision Date |
02/01/2022 |
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 |
|