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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
510(k) Number K192798
Device Name Zimmer Segmental System
Applicant
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Applicant Contact yoriko kobayashi
Correspondent
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Correspondent Contact yoriko kobayashi
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received09/30/2019
Decision Date 12/10/2020
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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