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Cortical Screw

by Orthopedic Systems, Inc.

510(k) K895217

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 NumberK895217 Date12 Sep 1989ClearedStatusActive

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  • Withdrawn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, 21 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 Cortical Screw is an orthopedic screw designed to anchor implants to dense cortical bone. It is used to fix fractures or attach plates to bones in trauma and orthopedic surgeries. The screw has a fine thread design with a small pitch, allowing tight engagement with the bone.

The Cortical Screw is supplied in various sizes, including 1.5mm, 2.0mm, 2.4mm, 2.7mm, and 4.5mm diameters, with lengths ranging from 12mm to 80mm. It is made of titanium material and is available in self-tapping and locking configurations. The device has received FDA 510K authorization.

Other devices from Orthopedic Systems, Inc.

See all devices from Orthopedic Systems, Inc. →

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Cortical Screw used for?

    The Cortical Screw is used to fix fractures or attach plates to bones in trauma and orthopedic surgeries, providing a secure anchor to dense cortical bone.

  • What sizes are available for the Cortical Screw?

    The Cortical Screw is supplied in various sizes, including 1.5mm, 2.0mm, 2.4mm, 2.7mm, and 4.5mm diameters, with lengths ranging from 12mm to 80mm.

  • What material is the Cortical Screw made of?

    The Cortical Screw is made of titanium material, providing strength and durability for orthopedic applications.

  • Is the Cortical Screw available in different configurations?

    Yes, the Cortical Screw is available in self-tapping and locking configurations, allowing for flexibility in surgical procedures.