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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, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
510(k) Number K212512
Device Name G7® Vivacit-E® Freedom® Constrained Liner
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Romil Sheth
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Adam Haas
Regulation Number888.3310
Classification Product Code
PBI  
Subsequent Product Codes
JDI   KWZ   LPH   LZO   OQG  
OQH   OQI  
Date Received08/10/2021
Decision Date 04/28/2022
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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