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Sofamor Laurain Dewald Anterior Fixation

by Sofamor Co.

510(k) K940744

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)SN Traditional NumberK940744 Date30 Jan 1996DecidedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 19 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 device is an anterior fixation system for spinal stabilization. It is designed to provide stabilization during the development of a solid spinal fusion.

It is supplied by Sofamor Co. and was cleared via FDA 510(k) pathway under K940744 with product code KWQ. The device is intended for use in orthopedic spinal procedures as a substantially equivalent device for some indications.

Other devices from Sofamor Co.

Questions

AI-generated answers, 19 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 SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION device used for?

    The device is an anterior fixation system designed to provide stabilization during the development of a solid spinal fusion. It is used in orthopedic spinal procedures to support spinal stabilization as part of the fusion process.

  • How was the SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION device cleared for market?

    The device was cleared via the FDA 510(k) pathway under submission K940744. It was determined to be substantially equivalent for some indications, with product code KWQ and review by the Orthopedic advisory committee.

  • Who manufactures the SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION device and where is it located?

    The device is manufactured by Sofamor Co., located at 158, Rue De L'Eglise - B.P.4, 62180 Rang Du Fliers, France. The applicant and contact listed is Brian Gooden.