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FDA 510(k)

ORBITAL RECONSTRUCTION PLATES

K-Number: K973982 · 1998-01-12

ApplicantHowmedica, Inc.
Decision Date1998-01-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORBITAL RECONSTRUCTION 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 1998-01-12 under 510(k) number K973982. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBITAL RECONSTRUCTION PLATES?

ORBITAL RECONSTRUCTION PLATES is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Howmedica, Inc.. The 510(k) number is K973982.

When did ORBITAL RECONSTRUCTION PLATES receive FDA 510(k) clearance?

ORBITAL RECONSTRUCTION PLATES received FDA 510(k) clearance on 1998-01-12, under 510(k) number K973982.

Who is the listed applicant for ORBITAL RECONSTRUCTION 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 ORBITAL RECONSTRUCTION PLATES?

The FDA product code for ORBITAL RECONSTRUCTION PLATES is HRS.

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Other records listing Howmedica, Inc. as applicant

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Related Devices (Code: HRS)

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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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