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M3 Lag Screw Fixation System

by Osteomed Corp.

510(k) K924018

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 NumberK924018 Date1 Apr 1993ClearedStatusActive

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  • Withdrawn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 M3 Lag Screw Fixation System is a screw, fixation, bone device classified under product code HWC. It is designed for the fixation of small bone osteotomies, fractures, arthrodesis, and reconstruction procedures in the upper and lower extremities.

The system includes lag screws and fully threaded screws in various sizes and lengths, featuring color-coded instrumentation to assure accuracy. It is supplied as a non-sterile, reusable system and was cleared via the FDA 510(k) pathway under K924018, with a traditional clearance decision based on substantial equivalence to a predicate device.

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Questions

AI-generated answers, 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.

  • What is the M3 Lag Screw Fixation System used for?

    The M3 Lag Screw Fixation System is designed for the fixation of small bone osteotomies, fractures, arthrodesis, and reconstruction procedures in both upper and lower extremities. It provides stable internal fixation to support bone healing in these surgical applications.

  • How is the M3 Lag Screw Fixation System supplied and is it sterile?

    The system is supplied as a non-sterile, reusable set that includes lag screws and fully threaded screws in various sizes and lengths, along with color-coded instrumentation. It must be sterilized by the user before each surgical use.

  • What sizes and types of screws are included in the M3 Lag Screw Fixation System?

    The system includes lag screws and fully threaded screws in various sizes and lengths, though specific dimensions are not detailed in the provided data. The screws are accompanied by color-coded instrumentation to assist with accurate selection and placement during surgery.

  • What regulatory pathway was used for the M3 Lag Screw Fixation System?

    The M3 Lag Screw Fixation System was cleared via the FDA 510(k) pathway under submission K924018, with a traditional clearance decision based on substantial equivalence to a predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.