|
Device | REFLECTION CERAMIC HIP SYSTEM (RCHS) |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P030022 |
Supplement Number | S021 |
Date Received | 02/01/2012 |
Decision Date | 06/28/2012 |
Withdrawal Date
|
08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF AN ALTERNATE SITE FOR THE MACHINING PROCESSES FOR R3 ACETABULAR SHELLS. |