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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 K200823
Device Name Zimmer, Inc. Hip Joint Prostheses MR Labeling I
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46861 -0708
Applicant Contact Caleb Barylski
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46861 -0708
Correspondent Contact Caleb Barylski
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   KWZ   LPH   LWJ   LZO  
OQG   OQH   OQI  
Date Received03/30/2020
Decision Date 07/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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