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FDA 510(k)

MANDIBULAR BONE DISTRACTOR

K-Number: K945674 · 1995-06-02

ApplicantHowmedica Corp.
Decision Date1995-06-02
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MANDIBULAR BONE DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K945674. 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 MANDIBULAR BONE DISTRACTOR?

MANDIBULAR BONE DISTRACTOR is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Howmedica Corp.. The 510(k) number is K945674.

When did MANDIBULAR BONE DISTRACTOR receive FDA 510(k) clearance?

MANDIBULAR BONE DISTRACTOR received FDA 510(k) clearance on 1995-06-02, under 510(k) number K945674.

Who is the listed applicant for MANDIBULAR BONE DISTRACTOR?

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

What is the FDA product code for MANDIBULAR BONE DISTRACTOR?

The FDA product code for MANDIBULAR BONE DISTRACTOR is MQN.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: MQN)

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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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