TenoTac Soft Tissue Fixation System

Fastener, Fixation, Nondegradable, Soft Tissue

Paragon 28, Inc

The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Tenotac Soft Tissue Fixation System.

Pre-market Notification Details

Device IDK203385
510k NumberK203385
Device Name:TenoTac Soft Tissue Fixation System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Paragon 28, Inc 14445 Grasslands Dr. Englewood,  CO  80112
ContactHaylie Hertz
CorrespondentHaylie Hertz
Paragon 28, Inc 14445 Grasslands Dr. Englewood,  CO  80112
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-18
Decision Date2021-02-11

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