R3ACT Stabilization System

Screw, Fixation, Bone

Paragon 28, Inc.

The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for R3act Stabilization System.

Pre-market Notification Details

Device IDK211770
510k NumberK211770
Device Name:R3ACT Stabilization System
ClassificationScrew, Fixation, Bone
Applicant Paragon 28, Inc. 14445 Grasslands Dr. Englewood,  CO  80112
ContactHaylie Hertz
CorrespondentHaylie Hertz
Paragon 28, Inc. 14445 Grasslands Dr. Englewood,  CO  80112
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2021-12-25

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