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FDA 510(k)

OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM

K-Number: K063792 · 2007-03-02

ApplicantOsteomed LP
Decision Date2007-03-02
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063792. 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 OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM?

OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Osteomed LP. The 510(k) number is K063792.

When did OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM receive FDA 510(k) clearance?

OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063792.

Who is the listed applicant for OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM?

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

What is the FDA product code for OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM?

The FDA product code for OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM is MQN.

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Other records listing Osteomed LP as applicant

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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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