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Titanium CD Horizon Anterior Spinal System

by Sofamor Danek USA, Inc.

510(k) K964623

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)SN Traditional NumberK964623 Date6 Feb 1997DecidedStatusActive

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  • Withdrawn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
KWQ
FDA applicant
Sofamor Danek USA,Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SN

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 Anterior Spinal System is a medical device intended for use in spinal surgery. It is designed to provide stabilization and support in the anterior column of the spine.

This system is supplied as a reusable implant system and is indicated for use in patients with degenerative disc disease as defined by back pain of discogenic origin with disc degeneration confirmed by patient history and radiographic studies. It received FDA 510(k) clearance under K964623 on February 6, 1997, and is classified under product code KWQ with an orthopedic advisory committee review.

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