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Synthes (USA) 2.0MM Titanium T-Plate

by Synthes (Usa)

510(k) K072758

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 NumberK072758 Date18 Dec 2007ClearedStatusActive

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  • Withdrawn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
GWO
Device Class
Class II
Regulation
21 CFR Part 882.5320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Synthes (USA) 2.0mm Titanium T-Plate is a preformed, alterable plate intended for use in the reconstruction of the cranium following surgical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation. The plate design is also intended for non-load bearing fixation, including cranial bone fixation.

This device is supplied as a single-use titanium plate and is classified as a Class II medical device under product code GWO with special controls. It received FDA 510(k) clearance on December 18, 2007, with the K number K072758. The plate is manufactured by Synthes (USA) in West Chester, PA, and is intended for use in neurology procedures.

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Questions

AI-generated answers, 27 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 Synthes 2.0mm Titanium T-Plate used for?

    The Synthes 2.0mm Titanium T-Plate is a preformed, alterable plate intended for use in the reconstruction of the cranium following surgical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation.

  • Is the Synthes 2.0mm Titanium T-Plate single-use or reusable?

    The Synthes 2.0mm Titanium T-Plate is supplied as a single-use titanium plate and is classified as a Class II medical device under product code GWO with special controls. It is not intended for reuse.

  • What is the regulatory status of the Synthes 2.0mm Titanium T-Plate?

    The Synthes 2.0mm Titanium T-Plate received FDA 510(k) clearance on December 18, 2007, with the K number K072758. It is classified as a Class II medical device under product code GWO with special controls and is intended for use in neurology procedures.

  • How is the Synthes 2.0mm Titanium T-Plate supplied?

    The Synthes 2.0mm Titanium T-Plate is supplied as a single-use titanium plate. It is manufactured by Synthes (USA) in West Chester, PA, and is intended for use in neurology procedures for cranium reconstruction following surgical decompression.