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 | NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE |
Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P910016 |
Supplement Number | S008 |
Date Received | 12/23/1996 |
Decision Date | 01/29/1997 |
Withdrawal Date
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04/18/2012 |
Product Code |
MBD |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SIX SIZE OPTIONS, TWO FIXATION PEGS ON THE FEMORAL COMPONENT, A 7 DEGREE DISTAL BONE CUT SURFACE ON THE FEMORAL COMPONENT, AND A SINGLE MENISCAL BEARING TRACK ACROSS ALL SIZES OF THE TIBIAL COMPONENT FOR THE SECOND GENERATION OF TH E NEW JERSEY LCS TOTAL KNEE SYSTEM UNICOMPARTMENTAL DEVICE CONFIGURATION. |
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