Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S006 |
Date Received | 11/02/2005 |
Decision Date | 08/30/2007 |
Product Code |
NRA |
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 FOLLOWING CHANGES IN THE MANUFACTURING PROCESSES FOR THE TIBIAL, MENISCAL BEARING, AND FEMORAL COMPONENTS FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEED SYSTEM: 1) ADDITION OF INSPECTION CHECKS; AND 2) ADDITION OF PREWASHES. |
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