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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 K191449
Device Name ZCA All-Poly Acetabular Cups
Applicant
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Applicant Contact Caleb Barylski
Correspondent
Zimmer, Inc.
1800 W. Center Street
Warsaw,  IN  46580
Correspondent Contact Caleb Barylski
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/31/2019
Decision Date 07/16/2020
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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