CPT Hip System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Zimmer Inc

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

Pre-market Notification Details

Device IDK191735
510k NumberK191735
Device Name:CPT Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant Zimmer Inc 1800 W Center Street Warsaw,  IN  46580
ContactCaleb Barylski
CorrespondentCaleb Barylski
Zimmer Inc 1800 W Center Street Warsaw,  IN  46580
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-28
Decision Date2020-03-20

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