ALLthread PEEK Suture Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

Biomet Inc.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Allthread Peek Suture Anchor.

Pre-market Notification Details

Device IDK193402
510k NumberK193402
Device Name:ALLthread PEEK Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
ContactHaley Pioch
CorrespondentHaley Pioch
Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2020-03-05

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