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FDA 510(k)

External Fixation Mini Rail System

K-Number: K252106 · 2025-09-30

ApplicantParagon 28, Inc.
Decision Date2025-09-30
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

External Fixation Mini Rail System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-09-30 under approval number K252106. 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 External Fixation Mini Rail System?

External Fixation Mini Rail System is a medical device that received FDA 510(k) clearance on 2025-09-30. It is manufactured by Paragon 28, Inc.. The 510(k) number is K252106.

When was External Fixation Mini Rail System approved by the FDA?

External Fixation Mini Rail System received FDA 510(k) clearance on 2025-09-30, under approval number K252106.

What company makes External Fixation Mini Rail System?

External Fixation Mini Rail System is manufactured by Paragon 28, Inc..

What is the FDA product code for External Fixation Mini Rail System?

The FDA product code for External Fixation Mini Rail System is KTT.

Related Clinical Trials

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Related PubMed Literature

PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

Other Devices by Paragon 28, Inc.

K170693Phantom Small Bone Intramedullary Nail System K182148SILVERBACK Gorilla Plating System K191782TTC Phantom Intramedullary Nail System K190365Baby Gorilla/Gorilla Plating System K190586Monster® Screw System K183690Tenodesis Screw System

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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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