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Titanium CD Horizon Spinal System

by Sofamor Danek USA, Inc.

510(k) K962708

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 NumberK962708 Date6 Feb 1997ClearedStatusActive

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  • Withdrawn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
KWP
FDA applicant
Sofamor Danek USA,Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3050
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 Titanium CD Horizon Spinal System is a spinal fixation device consisting of rods, hooks, screws, cross-link plates, staples, and connecting components. It is designed to be rigidly locked into various configurations to provide spinal stabilization, and may incorporate implants from other Medtronic Sofamor Danek spinal systems.

The system is supplied in titanium and stainless steel, with rod diameters of 4.5 mm, 5.5 mm, and/or 6.35 mm. It is intended for use with device-specific instruments and was cleared through the FDA 510(k) process under K962708, with a traditional clearance and substantially equivalent determination. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety information is included.

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