|
Device | BIRMINGHAM HIP RESURFACING SYSTEM (BHR) |
Generic Name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P040033 |
Supplement Number | S017 |
Date Received | 10/18/2010 |
Decision Date | 10/14/2011 |
Product Code |
NXT |
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 THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS. |