Comprehensive Segmental Revision System (SRS)

Shoulder Prosthesis, Reverse Configuration

Biomet Manufacturing Corp.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Segmental Revision System (srs).

Pre-market Notification Details

Device IDK173411
510k NumberK173411
Device Name:Comprehensive Segmental Revision System (SRS)
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Biomet Manufacturing Corp. 56 East Bell Drive Warsaw,  IN  46580
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
Biomet Manufacturing Corp. 56 East Bell Drive Warsaw,  IN  46580
Product CodePHX  
Subsequent Product CodeJDC
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-01
Decision Date2018-02-08
Summary:summary

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