BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bio-modular Shoulder System With Hydroxyapatite (ha) Coated Glenoid Components.

Pre-market Notification Details

Device IDK043100
510k NumberK043100
Device Name:BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBF  
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-09
Decision Date2005-02-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304443044 K043100 000
00880304434127 K043100 000
00880304433496 K043100 000

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