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Oss/(Scarf)- And Osw-Screw

by O.M.T. Oberflachen-Und Materialtechnologie GmbH

510(k) K042079

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 NumberK042079 Date20 Dec 2004ClearedStatusActive

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  • Withdrawn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, 27 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 Oss/(Scarf)- And Osw-Screw is a screw, fixation, bone device, classified as a medical specialty orthopedic device. It is used for bone fixation. The device is a type of screw used in orthopedic applications.

The device is supplied with a product code of HWC and is regulated under 21 CFR 888.3040. It has been assigned a k number of K042079 and has been determined to be substantially equivalent. The device is a class 2 device with a traditional clearance type.

Questions

AI-generated answers, 27 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 OSS/(Scarf)- And Osw-Screw used for?

    The OSS/(Scarf)- And Osw-Screw is used for bone fixation in orthopedic applications, providing a means to secure and stabilize bones during the healing process.

  • How is the device supplied?

    The device is supplied with a product code of HWC, which is a unique identifier for the device.

  • What regulatory classification does the device have?

    The device is classified as a class 2 device with a traditional clearance type, and has been determined to be substantially equivalent with a k number of K042079.