|
Device | REFLECTION CERAMIC ACETABULAR SYSTEM |
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 | S041 |
Date Received | 11/23/2016 |
Decision Date | 12/08/2016 |
Withdrawal Date
|
08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of an inspection procedure to the Ceramic Femoral Heads used with the Reflection and R3 Ceramic Liners. |