POROUS COATED COMPREHENSIVE FRACTURE STEMS

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 Porous Coated Comprehensive Fracture Stems.

Pre-market Notification Details

Device IDK140652
510k NumberK140652
Device Name:POROUS COATED COMPREHENSIVE FRACTURE STEMS
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
ContactBrian Kincaid
CorrespondentBrian Kincaid
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-14
Decision Date2014-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304591578 K140652 000
00880304591561 K140652 000
00880304591554 K140652 000
00880304591547 K140652 000
00880304591530 K140652 000
00880304591523 K140652 000

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