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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/polymer, porous uncemented
510(k) Number K183457
Device Name Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact Rebecca Nofiz
Correspondent
ZimmerBiomet
Waterton Ind Estate
Bridgend,  GB CF31 3XA
Correspondent Contact Dean Heit
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   KWZ   LZO   OQG  
OQH   OQI   PBI  
Date Received12/13/2018
Decision Date 11/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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