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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 K192416
Device Name BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Roberto Tommasini
Correspondent
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Neha Sreenath
Regulation Number888.3353
Classification Product Code
LZO  
Date Received09/04/2019
Decision Date 10/01/2019
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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