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. |
|
Device | OXFORD MENISCAL UNICOMPARTMENTAL 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 | S017 |
Date Received | 08/22/2007 |
Decision Date | 02/20/2008 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY. |
|
|