STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Stageone Select Cement Spacer Molds For Temporary Hip Replacement.

Pre-market Notification Details

Device IDK080979
510k NumberK080979
Device Name:STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-04-07
Decision Date2008-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304521995 K080979 000
00880304521056 K080979 000
00880304521063 K080979 000
00880304521070 K080979 000
00880304521087 K080979 000
00880304521094 K080979 000
00880304521100 K080979 000
00880304521117 K080979 000
00880304521124 K080979 000
00880304521131 K080979 000
00880304521148 K080979 000
00880304521155 K080979 000
00880304521162 K080979 000
00880304521179 K080979 000
00880304521230 K080979 000
00880304521247 K080979 000
00880304521254 K080979 000
00880304521032 K080979 000

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