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FDA 510(k)

LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES

K-Number: K901941 · 1990-09-06

ApplicantHowmedica Corp.
Decision Date1990-09-06
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1990-09-06 under 510(k) number K901941. 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 LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES?

LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES is a medical device that received FDA 510(k) clearance on 1990-09-06. The listed applicant is Howmedica Corp.. The 510(k) number is K901941.

When did LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES receive FDA 510(k) clearance?

LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES received FDA 510(k) clearance on 1990-09-06, under 510(k) number K901941.

Who is the listed applicant for LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES?

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

What is the FDA product code for LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES?

The FDA product code for LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES is JEY.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: JEY)

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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