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FDA 510(k)

Monkey Bars Pin to Bar External Fixation System

K-Number: K242452 · 2024-11-01

ApplicantParagon 28, Inc.
Decision Date2024-11-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monkey Bars Pin to Bar External Fixation System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242452. 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 Bars Pin to Bar External Fixation System?

Monkey Bars Pin to Bar External Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Paragon 28, Inc.. The 510(k) number is K242452.

When was Monkey Bars Pin to Bar External Fixation System approved by the FDA?

Monkey Bars Pin to Bar External Fixation System received FDA 510(k) clearance on 2024-11-01, under approval number K242452.

What company makes Monkey Bars Pin to Bar External Fixation System?

Monkey Bars Pin to Bar External Fixation System is manufactured by Paragon 28, Inc..

What is the FDA product code for Monkey Bars Pin to Bar External Fixation System?

The FDA product code for Monkey Bars Pin to Bar 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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