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Mandibular Bone Distractor

by Howmedica Corp.

510(k) K945674

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945674 Date2 Jun 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQN
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mandibular Bone Distractor is an External Mandibular Fixator And/Or Distractor, classified under product code MQN and regulation number 872.4760. It is a Class II medical device with a dental specialty designation, designed for mandibular bone distraction procedures.

The device received FDA 510(k) clearance K945674 on June 2, 1995, following a substantially equivalent determination. It was submitted by Howmedica Corp. and is subject to special controls as a Class II device. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.

Other devices from Howmedica Corp.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mandibular Bone Distractor used for?

    The Mandibular Bone Distractor is designed for mandibular bone distraction procedures, as it is classified as an External Mandibular Fixator And/Or Distractor with a dental specialty designation.

  • How was the Mandibular Bone Distractor authorized for market?

    The device received FDA 510(k) clearance K945674 on June 2, 1995, following a substantially equivalent determination, which means it was found to be substantially equivalent to a legally marketed predicate device.

  • What regulatory class and product code apply to the Mandibular Bone Distractor?

    The Mandibular Bone Distractor is classified as a Class II medical device under product code MQN and regulation number 872.4760, with a dental specialty designation as indicated in the FDA submission data.