FDA 510(k)

AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES

K-Number: K112455 · 2011-09-22

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2011-09-22

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2011-09-22 under 510(k) number K112455. 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 AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES?

AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K112455.

When did AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES receive FDA 510(k) clearance?

AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES received FDA 510(k) clearance on 2011-09-22, under 510(k) number K112455.

Who is the listed applicant for AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES?

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

What is the FDA product code for AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES?

The FDA product code for AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES is HRS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.