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FDA 510(k)

DNE EXTERNAL FIXATION SYSTEM

K-Number: K113106 · 2012-01-04

ApplicantDne, LLC
Decision Date2012-01-04
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DNE 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 2012-01-04 under 510(k) number K113106. 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 DNE EXTERNAL FIXATION SYSTEM?

DNE EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-04. The listed applicant is Dne, LLC. The 510(k) number is K113106.

When did DNE EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

DNE EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2012-01-04, under 510(k) number K113106.

Who is the listed applicant for DNE 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 DNE EXTERNAL FIXATION SYSTEM?

The FDA product code for DNE EXTERNAL FIXATION SYSTEM is KTT.

Related Clinical Trials

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.

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Other records listing Dne, LLC as applicant

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.

K151580D.N.E. External Fixation System

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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