Cordera 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 Cordera Hip System.

Pre-market Notification Details

Device IDK202484
510k NumberK202484
Device Name:Cordera Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Conformis, Inc. 600 Technology Park Drive Billerica,  MA  01821
ContactNancy Giezen
CorrespondentNancy Giezen
Conformis, Inc. 600 Technology Park Drive Billerica,  MA  01821
Product CodeLPH  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
Subsequent Product CodeOQG
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2020-09-24

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