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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
Device Name NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
Applicant
Zimmer Trabecular Metal Technology
10 Pomeroy Rd.
Parsippany,  NJ  07054
Applicant Contact JUDITH ROSEN
Correspondent
Zimmer Trabecular Metal Technology
10 Pomeroy Rd.
Parsippany,  NJ  07054
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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