Zimmer Segmental System

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System.

Pre-market Notification Details

Device IDK192798
510k NumberK192798
Device Name:Zimmer Segmental System
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactYoriko Kobayashi
CorrespondentYoriko Kobayashi
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeKRO  
Subsequent Product CodeJDI
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-12-10

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