Comprehensive Vault Reconstruction System

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 Vault Reconstruction System.

Pre-market Notification Details

Device IDK202232
510k NumberK202232
Device Name:Comprehensive Vault Reconstruction System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Biomet Manufacturing Corp. 56 E. Bell Drive Warsaw,  IN  46582
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
Biomet Manufacturing Corp. 56 E. Bell Drive Warsaw,  IN  46582
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2021-02-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.