Skip to content

CD Horizon™ Spinal System

by Medtronic 2 variants

510(k) K221244

CD Horizon™ Spinal System is a Class II device made by Medtronic, cleared under FDA 510(k) K221244 on 25 May 2022, active as of 25 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 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221244 Date25 May 2022ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K221244

935 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221244
UDI-DISize and differences
CD Horizon™ ModuLeX™ Spinal System 26024500
MEDTRONIC SOFAMOR DANEK, INC.
2602450000763000587291
Single use: no
On the market
CD Horizon™ ModuLeX™ Spinal System 26394500
MEDTRONIC SOFAMOR DANEK, INC.
2639450000763000592011
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55900504022
MEDTRONIC SOFAMOR DANEK, INC.
5590050402200763000592035
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55900505545
MEDTRONIC SOFAMOR DANEK, INC.
5590050554500763000592431
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901504532
MEDTRONIC SOFAMOR DANEK, INC.
5590150453200763000599089
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901504535
MEDTRONIC SOFAMOR DANEK, INC.
5590150453500763000599096
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901505015
MEDTRONIC SOFAMOR DANEK, INC.
5590150501500763000599140
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901505525
MEDTRONIC SOFAMOR DANEK, INC.
5590150552500763000599294
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901505550
MEDTRONIC SOFAMOR DANEK, INC.
5590150555000763000599362
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55901506525
MEDTRONIC SOFAMOR DANEK, INC.
5590150652500763000599515
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902504522
MEDTRONIC SOFAMOR DANEK, INC.
5590250452220763000965475
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902505022
MEDTRONIC SOFAMOR DANEK, INC.
5590250502220763000599991
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902505050
MEDTRONIC SOFAMOR DANEK, INC.
5590250505020763000600079
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902505527
MEDTRONIC SOFAMOR DANEK, INC.
5590250552720763000606989
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902505545
MEDTRONIC SOFAMOR DANEK, INC.
5590250554520763000607030
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902506030
MEDTRONIC SOFAMOR DANEK, INC.
5590250603020763000965857
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902506055
MEDTRONIC SOFAMOR DANEK, INC.
5590250605520763000965901
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55902506555
MEDTRONIC SOFAMOR DANEK, INC.
5590250655520763000607252
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504040
MEDTRONIC SOFAMOR DANEK, INC.
5590350404020763000607498
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504045
MEDTRONIC SOFAMOR DANEK, INC.
5590350404520763000966120
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504050
MEDTRONIC SOFAMOR DANEK, INC.
5590350405020763000966137
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504515
MEDTRONIC SOFAMOR DANEK, INC.
5590350451520763000607535
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504540
MEDTRONIC SOFAMOR DANEK, INC.
5590350454020763000604657
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903504550
MEDTRONIC SOFAMOR DANEK, INC.
5590350455020763000604671
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903505015
MEDTRONIC SOFAMOR DANEK, INC.
5590350501520763000604695
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903505025
MEDTRONIC SOFAMOR DANEK, INC.
5590350502520763000966304
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903505515
MEDTRONIC SOFAMOR DANEK, INC.
5590350551520763000604817
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903506520
MEDTRONIC SOFAMOR DANEK, INC.
5590350652020763000966632
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55903506530
MEDTRONIC SOFAMOR DANEK, INC.
5590350653020763000605074
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200017
MEDTRONIC SOFAMOR DANEK, INC.
55920001720763000972657
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200024
MEDTRONIC SOFAMOR DANEK, INC.
55920002420763000607597
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200024
MEDTRONIC SOFAMOR DANEK, INC.
55920002420763000972725
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200032
MEDTRONIC SOFAMOR DANEK, INC.
55920003220763000608259
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200035
MEDTRONIC SOFAMOR DANEK, INC.
55920003500763000972837
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200037
MEDTRONIC SOFAMOR DANEK, INC.
55920003720763000607665
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200047
MEDTRONIC SOFAMOR DANEK, INC.
55920004700763000607739
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 559200065
MEDTRONIC SOFAMOR DANEK, INC.
55920006520763000608563
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 5593001
MEDTRONIC SOFAMOR DANEK, INC.
559300100763000608392
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946006050
MEDTRONIC SOFAMOR DANEK, INC.
5594600605000763000594664
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946104032
MEDTRONIC SOFAMOR DANEK, INC.
5594610403200763000971526
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946104035
MEDTRONIC SOFAMOR DANEK, INC.
5594610403500763000591052
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946104535
MEDTRONIC SOFAMOR DANEK, INC.
5594610453500763000971618
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946105045
MEDTRONIC SOFAMOR DANEK, INC.
5594610504500763000591243
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946105525
MEDTRONIC SOFAMOR DANEK, INC.
5594610552500763000971731
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946107550
MEDTRONIC SOFAMOR DANEK, INC.
5594610755000763000591472
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946204527
MEDTRONIC SOFAMOR DANEK, INC.
5594620452720763000591599
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946204530
MEDTRONIC SOFAMOR DANEK, INC.
5594620453020763000972985
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 55946206030
MEDTRONIC SOFAMOR DANEK, INC.
5594620603020763000608082
Single use: yes
On the market
CD Horizon™ ModuLeX™ Spinal System 5596079
MEDTRONIC SOFAMOR DANEK, INC.
559607900763000825843
Single use: no
On the market
CD Horizon™ ModuLeX™ Spinal System 5597416
MEDTRONIC SOFAMOR DANEK, INC.
559741600763000825867
Single use: no
On the market

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →