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 PARTIAL KNEE |
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 | S031 |
Date Received | 05/31/2011 |
Decision Date | 07/29/2011 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE SURGICAL TECHNIQUE BROCHURE FOR THE OXFORD PARTIAL KNEE SYSTEM THAT INCLUDE THE ADDITION OF INSTRUCTIONS FOR USE FOR THE SIGNATURE PERSONALIZED PATIENT CARE SYSTEM (PATIENT-MATCHED CUTTING/DRILLING GUIDES.) |
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