|
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 | S003 |
Date Received | 04/20/2006 |
Decision Date | 08/14/2007 |
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 A CHANGE TO THE POROUS COATING PROCESS FOR THE REFLECTION CERAMIC ACETABULAR SHELL TEST COUPON. |