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FDA 510(k)

DISTRAX

K-Number: K080542 · 2008-12-15

ApplicantJohn W. King
Decision Date2008-12-15
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISTRAX is the device name listed in this FDA 510(k) record. The listed applicant is John W. King. It received FDA 510(k) clearance on 2008-12-15 under 510(k) number K080542. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISTRAX?

DISTRAX is a medical device that received FDA 510(k) clearance on 2008-12-15. The listed applicant is John W. King. The 510(k) number is K080542.

When did DISTRAX receive FDA 510(k) clearance?

DISTRAX received FDA 510(k) clearance on 2008-12-15, under 510(k) number K080542.

Who is the listed applicant for DISTRAX?

The FDA 510(k) record lists John W. King as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISTRAX?

The FDA product code for DISTRAX is MQN.

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Related Devices (Code: MQN)

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.

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, 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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