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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 the device name listed in this FDA 510(k) record. The listed applicant is Dne, LLC. It received FDA 510(k) clearance on 2016-02-16 under 510(k) 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. The listed applicant is Dne, LLC. The 510(k) number is K151580.

When did D.N.E. External Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for D.N.E. External Fixation System?

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

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 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, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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