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Monster Screw System

by Apogee Orthosolutions

510(k) K124027

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 NumberK124027 Date5 Apr 2013ClearedStatusActive

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  • Withdrawn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 Monster Screw System is an orthopedic device. It is a screw system used in orthopedic applications.

The device was cleared through the FDA 510(k) process under K124027 with product code HWC. It is supplied by Apogee Orthosolutions and is intended for use in orthopedic settings as indicated by its classification and authorization.

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 Monster Screw System used for?

    The Monster Screw System is an orthopedic device designed for use in orthopedic applications, as indicated by its classification and authorization under FDA 510(k) clearance K124027 with product code HWC.

  • How is the Monster Screw System supplied and by whom?

    The Monster Screw System is supplied by Apogee Orthosolutions, located in Chesterland, Ohio, as indicated by the manufacturer and address details in the authorization record.

  • What regulatory pathway was used for the Monster Screw System?

    The Monster Screw System was cleared through the FDA 510(k) process under K124027, with a traditional clearance type and a substantially equivalent decision, as documented in the device data.