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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, cemented
510(k) Number K210842
Device Name VerSys Cemented Revision/Calcar
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Applicant Contact Rhonda Myer
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Correspondent Contact Katherine Choi
Regulation Number888.3350
Classification Product Code
Date Received03/22/2021
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No