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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K161830
Device Name Zimmer M/L Taper Hip Prosthesis
Applicant
ZIMMER, INC.
P.O. BOX 708
Warsaw,  IN  46581
Applicant Contact RHONDA MYER
Correspondent
ZIMMER, INC.
P.O. BOX 708
Warsaw,  IN  46581
Correspondent Contact RHONDA MYER
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/05/2016
Decision Date 10/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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