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FDA 510(k)

VARIAX DISTAL RADIUS TORX SCREWS

K-Number: K080667 · 2008-03-19

ApplicantHowmedica Osteonics Corp.
Decision Date2008-03-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VARIAX DISTAL RADIUS TORX SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2008-03-19 under 510(k) number K080667. 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 VARIAX DISTAL RADIUS TORX SCREWS?

VARIAX DISTAL RADIUS TORX SCREWS is a medical device that received FDA 510(k) clearance on 2008-03-19. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K080667.

When did VARIAX DISTAL RADIUS TORX SCREWS receive FDA 510(k) clearance?

VARIAX DISTAL RADIUS TORX SCREWS received FDA 510(k) clearance on 2008-03-19, under 510(k) number K080667.

Who is the listed applicant for VARIAX DISTAL RADIUS TORX SCREWS?

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

What is the FDA product code for VARIAX DISTAL RADIUS TORX SCREWS?

The FDA product code for VARIAX DISTAL RADIUS TORX SCREWS is HRS.

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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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