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FDA 510(k)

SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR

K-Number: K043555 · 2005-04-12

ApplicantSynthes (Usa)
Decision Date2005-04-12
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-04-12 under 510(k) number K043555. 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 SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR?

SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR is a medical device that received FDA 510(k) clearance on 2005-04-12. The listed applicant is Synthes (Usa). The 510(k) number is K043555.

When did SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR receive FDA 510(k) clearance?

SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR received FDA 510(k) clearance on 2005-04-12, under 510(k) number K043555.

Who is the listed applicant for SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR?

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

What is the FDA product code for SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR?

The FDA product code for SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR is MQN.

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Other records listing Synthes (Usa) 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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