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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 K200959
Device Name Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
Applicant
Biomet UK Ltd.
Waterton Industrial Estate
Brigend,  GB CF31 3XA
Applicant Contact Caleb Barylski
Correspondent
Biomet UK Ltd.
Waterton Industrial Estate
Brigend,  GB CF31 3XA
Correspondent Contact Caleb Barylski
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MAY   OQG  
OQH   OQI  
Date Received04/10/2020
Decision Date 07/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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