BIO-MODULAR REVERSE SHOLDER

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 Bio-modular Reverse Sholder.

Pre-market Notification Details

Device IDK093803
510k NumberK093803
Device Name:BIO-MODULAR REVERSE SHOLDER
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-11
Decision Date2010-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304591219 K093803 000
00880304506930 K093803 000
00887868254062 K093803 000

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