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FDA 510(k)

VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES

K-Number: K100271 · 2010-05-14

ApplicantHowmedica Osteonics Corp.
Decision Date2010-05-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES 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 2010-05-14 under 510(k) number K100271. 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 VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES?

VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES is a medical device that received FDA 510(k) clearance on 2010-05-14. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K100271.

When did VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES receive FDA 510(k) clearance?

VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES received FDA 510(k) clearance on 2010-05-14, under 510(k) number K100271.

Who is the listed applicant for VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES?

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 VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES?

The FDA product code for VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES is HRS.

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Related Devices (Code: HRS)

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Official Source

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