FDA.report

510(k) K211770

Device
R3ACT Stabilization System
Applicant
Paragon 28, Inc.
510(k) number
K211770
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-25
Date received
2021-06-08
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Haylie Hertz
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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