|
Device | OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM |
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 | S016 |
Date Received | 08/10/2007 |
Decision Date | 09/12/2007 |
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 NEW FIXTURING TO BE USED DURING THE MANUFACTURING OF THE TIBIAL COMPONENTS OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM TO PREVENT COMPONENTS BEING MIS-MARKED. |