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Levtech Composite Traction Tongs

by Levtech, Inc.

510(k) K873693

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873693 Date5 Feb 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HAX
Device Class
Class II
Regulation
21 CFR Part 882.5960
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Levtech Composite Traction Tongs are a Tong, Skull for Traction (per FDA nomenclature), designed to immobilize a patient’s skull during cervical spine injury management. These tongs apply controlled traction by anchoring to the skull and applying a counterweight, aiding in the stabilization of fractures or dislocations. Constructed with composite materials, they are intended for precise, secure attachment to the cranial bone while minimizing tissue damage.

Used primarily in neurosurgical and emergency settings, these tongs are supplied sterile for single-use applications to prevent cross-contamination. They are classified as Class II devices under FDA regulations (21 CFR 882.5960) and require proper storage in a clean, dry environment to maintain sterility. Available in multiple sizes (as referenced in registration numbers 3004464325, 3002750084, etc.), they are intended for use under direct medical supervision in controlled clinical environments. FDA clearance (K873693) confirms their compliance with regulatory standards for traction devices in neurology

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