Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
More FDA Info for this Device |
510(K) Number |
K211742 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Applicant |
Signature Orthopaedics Pty Ltd.
7 Sirius Road
Lane Cove 2066 AU
Other 510(k) Applications for this Company
|
Contact |
Declan Brazil
Other 510(k) Applications for this Contact |
Regulation Number |
888.3353
More FDA Info for this Regulation Number |
Classification Product Code |
MEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/07/2021 |
Decision Date |
01/07/2022 |
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 |
|