Comprehensive Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Biomet Manufacturing Corp.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Shoulder System.

Pre-market Notification Details

Device IDK193038
510k NumberK193038
Device Name:Comprehensive Shoulder System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
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 CodeMBF  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-31
Decision Date2020-10-28

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