Conformis Hip System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Conformis, Inc.

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

Pre-market Notification Details

Device IDK192198
501k NumberK192198
Device Name:Conformis Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Conformis, Inc. 600 Technology Park Billerica,  MA  01821
ContactPaul Smolenski
CorrespondentPaul Smolenski
Conformis, Inc. 600 Technology Park Billerica,  MA  01821
Product CodeLPH  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
Subsequent Product CodeOQG
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-13
Decision Date2019-11-06

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