StageOne Knee Cement Spacer Molds

Bone Cement, Antibiotic

Biomet, Inc.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Knee Cement Spacer Molds.

Pre-market Notification Details

Device IDK213287
510k NumberK213287
Device Name:StageOne Knee Cement Spacer Molds
ClassificationBone Cement, Antibiotic
Applicant Biomet, Inc. 56 East Bell Drive Warsaw,  IN  46581
ContactAnuja Yardi
CorrespondentNeha Sreenath
Biomet, Inc. 56 East Bell Drive Warsaw,  IN  46581
Product CodeMBB  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-01
Decision Date2022-09-02

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.