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FDA 510(k)

Monkey Rings External Ring Fixation System

K-Number: K253613 · 2025-12-19

ApplicantParagon 28, Inc.
Decision Date2025-12-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monkey Rings External Ring Fixation System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253613. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monkey Rings External Ring Fixation System?

Monkey Rings External Ring Fixation System is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Paragon 28, Inc.. The 510(k) number is K253613.

When was Monkey Rings External Ring Fixation System approved by the FDA?

Monkey Rings External Ring Fixation System received FDA 510(k) clearance on 2025-12-19, under approval number K253613.

What company makes Monkey Rings External Ring Fixation System?

Monkey Rings External Ring Fixation System is manufactured by Paragon 28, Inc..

What is the FDA product code for Monkey Rings External Ring Fixation System?

The FDA product code for Monkey Rings External Ring Fixation System is KTT.

Related Clinical Trials

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Related Devices (Code: KTT)

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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.

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