Zimmer M/L Taper Hip Prosthesis

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis.

Pre-market Notification Details

Device IDK192660
510k NumberK192660
Device Name:Zimmer M/L Taper Hip Prosthesis
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactCaleb Barylski
CorrespondentCaleb Barylski
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2020-02-28

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