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FDA 510(k)

MODUS 2.5 MANDIBULAR RECONSTRUCTION SET

K-Number: K992682 · 1999-11-24

ApplicantMedartis AG
Decision Date1999-11-24
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODUS 2.5 MANDIBULAR RECONSTRUCTION SET is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 1999-11-24 under 510(k) number K992682. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODUS 2.5 MANDIBULAR RECONSTRUCTION SET?

MODUS 2.5 MANDIBULAR RECONSTRUCTION SET is a medical device that received FDA 510(k) clearance on 1999-11-24. The listed applicant is Medartis AG. The 510(k) number is K992682.

When did MODUS 2.5 MANDIBULAR RECONSTRUCTION SET receive FDA 510(k) clearance?

MODUS 2.5 MANDIBULAR RECONSTRUCTION SET received FDA 510(k) clearance on 1999-11-24, under 510(k) number K992682.

Who is the listed applicant for MODUS 2.5 MANDIBULAR RECONSTRUCTION SET?

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

What is the FDA product code for MODUS 2.5 MANDIBULAR RECONSTRUCTION SET?

The FDA product code for MODUS 2.5 MANDIBULAR RECONSTRUCTION SET is JEY.

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Related Devices (Code: JEY)

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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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