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FDA 510(k)

Extremity Medical External Fixation System

K-Number: K251128 · 2025-05-07

ApplicantExtremity Medical, LLC
Decision Date2025-05-07
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Extremity Medical External Fixation System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2025-05-07 under approval number K251128. 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 Extremity Medical External Fixation System?

Extremity Medical External Fixation System is a medical device that received FDA 510(k) clearance on 2025-05-07. It is manufactured by Extremity Medical, LLC. The 510(k) number is K251128.

When was Extremity Medical External Fixation System approved by the FDA?

Extremity Medical External Fixation System received FDA 510(k) clearance on 2025-05-07, under approval number K251128.

What company makes Extremity Medical External Fixation System?

Extremity Medical External Fixation System is manufactured by Extremity Medical, LLC.

What is the FDA product code for Extremity Medical External Fixation System?

The FDA product code for Extremity Medical External Fixation System is KTT.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Extremity Medical, LLC

K160191Align Anterior Ankle Fusion Plate K172260Omni Foot Plating System K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System K181067AlignX Ankle Fusion System K180808Omni Foot Plating System K192592Axis Plating 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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