COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)

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 (vrs).

Pre-market Notification Details

Device IDK152754
510k NumberK152754
Device Name:COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw,  IN  46580
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw,  IN  46580
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-24
Decision Date2016-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304834026 K152754 000
00880304818965 K152754 000
00889024563599 K152754 000
00880304818934 K152754 000
00880304818941 K152754 000
00880304826526 K152754 000
00880304829473 K152754 000
00880304829480 K152754 000
00880304829497 K152754 000
00880304829503 K152754 000
00880304829510 K152754 000
00880304829527 K152754 000
00880304818958 K152754 000

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