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Cd Horizon Spinal System

by Medtronic Sofamor Danek USA, Inc. 27 variants

510(k) K123809

Cd Horizon Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K123809 on 22 Feb 2013, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Special NumberK123809 Date22 Feb 2013ClearedStatusActive

Official records

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  • Withdrawn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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESU

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