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CD Horizon™ ModuLeX™ Spinal System 559200065

by Medtronic Sofamor Danek, Inc. 2 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K221244

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Overview

The CD Horizon ModuLeX Spinal System is a reliable and efficient orthopedic solution for treating spinal instabilities or deformities. Featuring a small, threaded implantable rod with a screw head and drive, this device provides immobilization and stabilization of the spine in various types, including pedicle and transfacet models. Made from non-bioabsorbable materials like surgical steel, titanium alloy, and carbon fibre, it is designed to promote healing and minimize complications.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20763000608563 UDI-DI Date11 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK221244 Date25 May 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221244 decided 25 May 2022 Active
  • FDA GUDID UDI-DI 20763000608563 listed 11 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221244
  2. Listed FDA GUDID 20763000608563

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CD Horizon™ ModuLeX™ Spinal System
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
559200065
Primary DI / UDI-DI
20763000608563
510(k) Number
FDA product code
KWQ, NKB, KWP
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K221244)

and 8 more cleared under K221244

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)