Conformis BeneFIT 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 Benefit Hip System.

Pre-market Notification Details

Device IDK190904
510k NumberK190904
Device Name:Conformis BeneFIT Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ConforMIS, Inc. 600 Technology Park Billerica,  MA  01821
ContactEmmanuel Nyakako
CorrespondentEmmanuel Nyakako
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-08
Decision Date2019-08-28

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