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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K120990
Models 00-5444-XXX-XX,00-5445-XXX-XX, 00-5446-XXX-XX,00-5447-XXX-XX
Device Name NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
Original Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY
10 pomeroy rd.
parsippany,  NJ  07054
Original Contact judith rosen
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/02/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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