Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

R3ACT Stabilization System

K-Number: K211770 · 2021-12-25

ApplicantParagon 28, Inc.
Decision Date2021-12-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R3ACT Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-12-25 under 510(k) number K211770. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R3ACT Stabilization System?

R3ACT Stabilization System is a medical device that received FDA 510(k) clearance on 2021-12-25. The listed applicant is Paragon 28, Inc.. The 510(k) number is K211770.

When did R3ACT Stabilization System receive FDA 510(k) clearance?

R3ACT Stabilization System received FDA 510(k) clearance on 2021-12-25, under 510(k) number K211770.

Who is the listed applicant for R3ACT Stabilization System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R3ACT Stabilization System?

The FDA product code for R3ACT Stabilization System is HWC. This falls under the Cardiovascular category.

Other records listing Paragon 28, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemK262047Grappler Suture Anchor SystemK253886Grappler Suture Anchor PCFD Tether SystemK253591Phantom® Hindfoot TTC/TC Nail SystemK253613Monkey Rings External Ring Fixation SystemK252106External Fixation Mini Rail System

View all 56 devices →

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑