Skip to content

Mcgrath Orthopaedic Bone Screws

by Mcgrath Surgical, Ltd.

510(k) K901814

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 NumberK901814 Date21 Aug 1990DecidedStatusActive

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  • Withdrawn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
FDA applicant
Mcgrath Surgical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

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 Mcgrath Orthopaedic Bone Screws are medical devices designed for the fixation of bones in orthopedic procedures. These screws are intended to provide stability and support during surgical bone repair.

This device is classified as a Class 2 medical device and received FDA 510(k) clearance under K901814 on August 21, 1990. It is manufactured by Mcgrath Surgical, Ltd.