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FDA 510(k)

MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM

K-Number: K051946 · 2005-08-22

ApplicantMedartis, Inc.
Decision Date2005-08-22
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medartis, Inc.. It received FDA 510(k) clearance on 2005-08-22 under 510(k) number K051946. 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 MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM?

MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is Medartis, Inc.. The 510(k) number is K051946.

When did MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM receive FDA 510(k) clearance?

MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM received FDA 510(k) clearance on 2005-08-22, under 510(k) number K051946.

Who is the listed applicant for MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM?

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

What is the FDA product code for MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM?

The FDA product code for MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM is MQN.

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Other records listing Medartis, Inc. 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.

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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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