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 a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-12-25 under approval 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. It is manufactured by Paragon 28, Inc.. The 510(k) number is K211770.
When was R3ACT Stabilization System approved by the FDA?
R3ACT Stabilization System received FDA 510(k) clearance on 2021-12-25, under approval number K211770.
What company makes R3ACT Stabilization System?
R3ACT Stabilization System is manufactured by Paragon 28, Inc..
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.
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Official Source
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