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Wisorb Malleolar Screw

by Cambridge Scientific, Inc.

510(k) K020222

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 NumberK020222 Date29 Jul 2002ClearedStatusActive

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  • Withdrawn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, 23 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 Wisorb Malleolar Screw is a smooth or threaded metallic bone fixation fastener used for orthopedic applications. It is designed for malleolar fixation, which involves stabilizing bones in the ankle region. The device is part of the Class II medical devices category under product code HWC.

The Wisorb Malleolar Screw is supplied as a single-use device and requires appropriate storage conditions. It received FDA 510(k) clearance with the number K020222 on July 29, 2002, and was determined to be substantially equivalent to other devices in its class. The device is regulated under 21 CFR 888.3040 for smooth or threaded metallic bone fixation fasteners.

Other devices from Cambridge Scientific, Inc.

Questions

AI-generated answers, 23 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 Wisorb Malleolar Screw used for?

    The Wisorb Malleolar Screw is a smooth or threaded metallic bone fixation fastener specifically designed for malleolar fixation, which involves stabilizing bones in the ankle region during orthopedic procedures.

  • Is the Wisorb Malleolar Screw a single-use device?

    Yes, the Wisorb Malleolar Screw is supplied as a single-use device and requires appropriate storage conditions to maintain its integrity until use.

  • What regulatory approvals does the Wisorb Malleolar Screw have?

    The Wisorb Malleolar Screw received FDA 510(k) clearance with number K020222 on July 29, 2002, and was determined to be substantially equivalent to other devices in its class. It is regulated under 21 CFR 888.3040 for smooth or threaded metallic bone fixation fasteners.

  • What is the product code classification for the Wisorb Malleolar Screw?

    The Wisorb Malleolar Screw is classified as a Class II medical device under product code HWC, which covers smooth or threaded metallic bone fixation fasteners used for orthopedic applications.