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CD Horizon Spinal System

by Medtronic Sofamor Danek, Inc. 29 variants

510(k) K001255

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 NumberK001255 Date11 Jul 2000ClearedStatusActive

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  • Withdrawn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
MNH
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
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 CD Horizon Spinal System is a modular orthopedic fixation device designed for posterior spinal stabilization. It includes rods, hooks, screws, plates, staples, and connecting components that enable customizable constructs for spinal fusion procedures. The system is intended for non-cervical applications and provides rigid fixation to support the spine during healing. Components may be integrated with other Medtronic Sofamor Danek spinal systems for tailored surgical solutions.

This system is supplied as a reusable surgical instrument set and is intended for single-patient use per sterile packaging. Components are compatible with MRI environments, though specific safety parameters must be verified preoperatively. The system is cleared by the FDA under 510(k) number K001255, with a traditional review process through the Orthopedic Devices Advisory Committee. Storage requires adherence to manufacturer guidelines for sterility and handling to ensure device integrity.

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