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FDA 510(k)

MODUS 2.5 MANDIBULAR TRAUMA SET

K-Number: K992683 · 1999-11-24

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

Device Summary

MODUS 2.5 MANDIBULAR TRAUMA 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 K992683. 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 TRAUMA SET?

MODUS 2.5 MANDIBULAR TRAUMA 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 K992683.

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

MODUS 2.5 MANDIBULAR TRAUMA SET received FDA 510(k) clearance on 1999-11-24, under 510(k) number K992683.

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

The FDA product code for MODUS 2.5 MANDIBULAR TRAUMA SET is 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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