Grappler Suture Anchor 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 Grappler Suture Anchor System.

Pre-market Notification Details

Device IDK211002
510k NumberK211002
Device Name:Grappler Suture Anchor 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 Received2021-04-02
Decision Date2021-07-07

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