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FDA 510(k)

Monkey RingsTM External Fixation System

K-Number: K232838 · 2023-10-12

ApplicantParagon 28, Inc.
Decision Date2023-10-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monkey RingsTM External Fixation System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-10-12 under approval number K232838. 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 RingsTM External Fixation System?

Monkey RingsTM External Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Paragon 28, Inc.. The 510(k) number is K232838.

When was Monkey RingsTM External Fixation System approved by the FDA?

Monkey RingsTM External Fixation System received FDA 510(k) clearance on 2023-10-12, under approval number K232838.

What company makes Monkey RingsTM External Fixation System?

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

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

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

Related Clinical Trials

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Other Devices by Paragon 28, Inc.

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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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