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Swing-Off Screw

by Advanced Interventional Technology, LLC

510(k) K130627

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 NumberK130627 Date21 Aug 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  • Withdrawn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, 25 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 Swing-Off Screw is a fixation screw designed for orthopedic applications. It is intended to be used for bone fixation procedures.

The device is supplied as a single-use item and is not MRI safe. It is stored according to standard medical device protocols and has FDA 510(k) clearance with the product code HWC.

Other devices from Advanced Interventional Technology, LLC

Questions

AI-generated answers, 25 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 Swing-Off Screw used for?

    The Swing-Off Screw is designed for orthopedic applications and is intended to be used for bone fixation procedures. It is a single-use device that helps stabilize bones during surgical interventions.

  • Is the Swing-Off Screw MRI safe?

    No, the Swing-Off Screw is not MRI safe. It should not be used in MRI environments as it may interfere with the imaging process or pose safety risks.

  • How is the Swing-Off Screw supplied and stored?

    The Swing-Off Screw is supplied as a single-use item and should be stored according to standard medical device protocols. This typically means keeping it in a clean, dry environment at room temperature until use.

  • What regulatory approvals does the Swing-Off Screw have?

    The Swing-Off Screw has FDA 510(k) clearance with the product code HWC. It was determined to be substantially equivalent to other legally marketed devices through the traditional clearance process.