Paratrooper Plantar Plate Repair 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 Paratrooper Plantar Plate Repair System.

Pre-market Notification Details

Device IDK191227
510k NumberK191227
Device Name:Paratrooper Plantar Plate Repair System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Paragon 28, Inc. 4B Inverness Ct. E, STE 280 Englewood,  CO  80112
ContactEric Lintula
CorrespondentEric Lintula
Paragon 28, Inc. 4B Inverness Ct. E, STE 280 Englewood,  CO  80112
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-07
Decision Date2020-01-24
Summary:summary

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