FDA 510(k)

NEWGEN/UNIVERSAL MANDIBULAR SYSTEM

K-Number: K014263 · 2002-03-08

Decision Date2002-03-08

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NEWGEN/UNIVERSAL MANDIBULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K014263. 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 NEWGEN/UNIVERSAL MANDIBULAR SYSTEM?

NEWGEN/UNIVERSAL MANDIBULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Stryker Instruments. The 510(k) number is K014263.

When did NEWGEN/UNIVERSAL MANDIBULAR SYSTEM receive FDA 510(k) clearance?

NEWGEN/UNIVERSAL MANDIBULAR SYSTEM received FDA 510(k) clearance on 2002-03-08, under 510(k) number K014263.

Who is the listed applicant for NEWGEN/UNIVERSAL MANDIBULAR SYSTEM?

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

What is the FDA product code for NEWGEN/UNIVERSAL MANDIBULAR SYSTEM?

The FDA product code for NEWGEN/UNIVERSAL MANDIBULAR SYSTEM is JEY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.