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Cannulated Plus Screw System

by Orthomatrix, Inc.

510(k) K010738

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010738 Date1 Aug 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cannulated Plus Screw System is a smooth or threaded metallic bone fixation fastener intended to be implanted. It consists of a stiff wire segment or rod made of alloys such as cobalt-chromium-molybdenum and stainless steel, and may be smooth on the outside, fully or partially threaded, straight or U-shaped.

The system is supplied by Orthomatrix, Inc. and is regulated under product code HWC with FDA 510(k) clearance K010738, granted on August 1, 2001. It is classified under regulation 888.3040 as a screw for bone fixation and is available in various sizes as specified by the manufacturer.

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