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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 K103517
Device Name TRABECULAR METAL FEMORAL CONE AUGMENTS
Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Applicant Contact JUDITH ROSEN
Correspondent
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Correspondent Contact JUDITH ROSEN
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received11/30/2010
Decision Date 02/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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