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FDA 510(k)

D.N.E. External Fixation System

K-Number: K151580 · 2016-02-16

ApplicantDne, LLC
Decision Date2016-02-16
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

D.N.E. External Fixation System is a medical device manufactured by Dne, LLC. It received FDA 510(k) clearance on 2016-02-16 under approval number K151580. 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 D.N.E. External Fixation System?

D.N.E. External Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-16. It is manufactured by Dne, LLC. The 510(k) number is K151580.

When was D.N.E. External Fixation System approved by the FDA?

D.N.E. External Fixation System received FDA 510(k) clearance on 2016-02-16, under approval number K151580.

What company makes D.N.E. External Fixation System?

D.N.E. External Fixation System is manufactured by Dne, LLC.

What is the FDA product code for D.N.E. External Fixation System?

The FDA product code for D.N.E. External Fixation System is KTT.

Related Clinical Trials

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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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