Skip to content

Cd Spinal System

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K000453

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 · Special NumberK000453 Date10 Mar 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  • Withdrawn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)

Full name
Modification to Cd Spinal System
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, 23 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 Cd Spinal System is a medical device designed for posterior, non-cervical spinal fixation. It is utilized to address conditions such as degenerative disc disease, which is defined as back pain of discogenic origin with degeneration.

This device is manufactured by Medtronic Sofamor Danek, Inc. and has received FDA 510(k) clearance. It is identified by the product code MNH and reference number K000453.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Questions

AI-generated answers, 23 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 primary clinical indication for the CD Spinal System?

    This device is intended for posterior, non-cervical spinal fixation. It is specifically indicated for patients suffering from degenerative disc disease, which is characterized by back pain of discogenic origin with associated degeneration.

  • What is the regulatory status of this spinal system?

    The CD Spinal System has received FDA 510(k) clearance under reference number K000453. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of the CD Spinal System?

    The device is manufactured by Medtronic Sofamor Danek, Inc., located in Memphis, Tennessee. The system is identified by product code MNH.