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Device | Oxford Partial Knee System - Bearing Components |
Generic Name | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581-0587 |
PMA Number | P010014 |
Supplement Number | S058 |
Date Received | 10/11/2016 |
Decision Date | 11/09/2016 |
Product Code |
NRA |
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 an additional inspection check for the Oxford Partial Knee Meniscal Bearing packaging. The additional check will require operators to visually inspect for presence of vacuum and that no movement of product should occur within the vacuum-sealed pouch. |