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 | NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | ZIMMER, INC. P.O. Box 708 Warsaw, IN 46581-0708 |
PMA Number | P060037 |
Supplement Number | S013 |
Date Received | 05/12/2010 |
Decision Date | 10/20/2010 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN INSPECTION STEP FOR THE FLUTED STEM MOBILE TIBIAL BASEPLATE ENGRAVED LINE FEATURE. |
|
|