TunneLoc Tibial Fixation Device

Fastener, Fixation, Nondegradable, Soft Tissue

Biomet Inc.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Tunneloc Tibial Fixation Device.

Pre-market Notification Details

Device IDK193092
510k NumberK193092
Device Name:TunneLoc Tibial Fixation Device
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46582
ContactHaley Pioch
CorrespondentHaley Pioch
Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46582
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-06
Decision Date2020-01-02

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