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FDA 510(k)

DYNEX® External Fixation Systems

K-Number: K260900 · 2026-04-17

ApplicantVilex, LLC
Decision Date2026-04-17
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNEX® External Fixation Systems is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K260900. 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 DYNEX® External Fixation Systems?

DYNEX® External Fixation Systems is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Vilex, LLC. The 510(k) number is K260900.

When did DYNEX® External Fixation Systems receive FDA 510(k) clearance?

DYNEX® External Fixation Systems received FDA 510(k) clearance on 2026-04-17, under 510(k) number K260900.

Who is the listed applicant for DYNEX® External Fixation Systems?

The FDA 510(k) record lists Vilex, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNEX® External Fixation Systems?

The FDA product code for DYNEX® External Fixation Systems is KTT.

Other records listing Vilex, LLC as applicant

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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbHK252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC

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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