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Arthrex Suture Anchor Screw System

by Arthrex, Inc.

510(k) K934327

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934327 Date15 Sep 1995ClearedStatusActive

Official records

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  • Withdrawn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
MBI
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Arthrex Suture Anchor Screw System is a type of orthopedic device used to repair soft tissue to bone. It is designed to provide a secure anchor point for sutures, allowing for a variety of anchor styles, materials, and suture configurations. The system is intended for use in orthopedic procedures.

The Arthrex Suture Anchor Screw System is supplied in various sizes, including 3.5 mm, 5.0 mm, and 6.5 mm diameters. It is a single-use device, and its use is limited to orthopedic procedures. The system has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device. The device is manufactured by Arthrex, Inc. and is available for use in medical settings.

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