BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

Bone Cement, Antibiotic

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Stage One Disposable Cement Spacer Molds For Temporary Hemi-shoulder Prosthesis.

Pre-market Notification Details

Device IDK131135
510k NumberK131135
Device Name:BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
ClassificationBone Cement, Antibiotic
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactCarmen Albany
CorrespondentCarmen Albany
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBB  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-04-22
Decision Date2014-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304551114 K131135 000
00887868543197 K131135 000
00887868543203 K131135 000
00887868543210 K131135 000
00887868543227 K131135 000
00880304551008 K131135 000
00880304551015 K131135 000
00880304551091 K131135 000
00880304551107 K131135 000
00887868543180 K131135 000

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