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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 K192683
Device Name Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Applicant
Biomet UK, Ltd.
Waterton Industrial Estate
Brigend,  GB CF31 3XA
Applicant Contact Lisa Ingram
Correspondent
Biomet UK, Ltd.
Waterton Industrial Estate
Brigend,  GB CF31 3XA
Correspondent Contact Lisa Ingram
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MAY   OQG  
OQH   OQI  
Date Received09/26/2019
Decision Date 02/27/2020
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
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