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FDA 510(k)

BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES

K-Number: K983885 · 1999-01-29

ApplicantHowmedica, Inc.
Decision Date1999-01-29
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1999-01-29 under 510(k) number K983885. 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 BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES?

BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Howmedica, Inc.. The 510(k) number is K983885.

When did BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES receive FDA 510(k) clearance?

BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES received FDA 510(k) clearance on 1999-01-29, under 510(k) number K983885.

Who is the listed applicant for BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES?

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

What is the FDA product code for BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES?

The FDA product code for BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES 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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