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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 K181171
Device Name Zimmer Biomet Ceramic Heads
Applicant
Zimmer, Inc
P.O Box 708
Warsaw,  IN  46581 -0708
Applicant Contact Carol Vierling
Correspondent
Zimmer, Inc
P.O Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact Carol Vierling
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   KWZ  
Date Received05/02/2018
Decision Date 04/02/2019
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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