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FDA 510(k)

TITANIUM MANDIBULAR FRACTURE SYSTEM

K-Number: K952168 · 1995-06-22

ApplicantMedicon, Inc.
Decision Date1995-06-22
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TITANIUM MANDIBULAR FRACTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K952168. 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 TITANIUM MANDIBULAR FRACTURE SYSTEM?

TITANIUM MANDIBULAR FRACTURE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Medicon, Inc.. The 510(k) number is K952168.

When did TITANIUM MANDIBULAR FRACTURE SYSTEM receive FDA 510(k) clearance?

TITANIUM MANDIBULAR FRACTURE SYSTEM received FDA 510(k) clearance on 1995-06-22, under 510(k) number K952168.

Who is the listed applicant for TITANIUM MANDIBULAR FRACTURE SYSTEM?

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

What is the FDA product code for TITANIUM MANDIBULAR FRACTURE SYSTEM?

The FDA product code for TITANIUM MANDIBULAR FRACTURE SYSTEM 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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