Cd Horizon Spinal System

by Medtronic Sofamor Danek, Inc. 29 variants

510(k) K112473

Cd Horizon Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K112473 on 21 Oct 2011, 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

510(k) K112473↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESU Special	NumberK112473	Date21 Oct 2011Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K112473

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K112473
FDA product code: NKB

Device class: Class II
Regulation: 21 CFR Part 888.3070
Advisory committee: Orthopedic
FDA decision: SESU

Devices cleared under K112473

378 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 K112473
		UDI-DI	Size and differences
CD HORIZON® Spinal System 54890001000 MEDTRONIC SOFAMOR DANEK, INC.	54890001000	00613994950802	Outer Diameter 10.0 mm; Length 100.0 mm	No longer on the market
CD HORIZON® Spinal System 54890001011 MEDTRONIC SOFAMOR DANEK, INC.	54890001011	00613994950796	Length 110.0 mm; Outer Diameter 10.0 mm	No longer on the market
CD HORIZON® Spinal System 54890001511 MEDTRONIC SOFAMOR DANEK, INC.	54890001511	00613994950727	Length 110.0 mm; Outer Diameter 10.5 mm	No longer on the market
CD HORIZON® Spinal System 54890004025 MEDTRONIC SOFAMOR DANEK, INC.	54890004025	00613994949752	Outer Diameter 4.0 mm; Length 25.0 mm	No longer on the market
CD HORIZON® Spinal System 54890004045 MEDTRONIC SOFAMOR DANEK, INC.	54890004045	00613994949714	Length 45.0 mm; Outer Diameter 4.0 mm	No longer on the market
CD HORIZON® Spinal System 54890004560 MEDTRONIC SOFAMOR DANEK, INC.	54890004560	00613994949592	Length 60.0 mm; Outer Diameter 4.5 mm	No longer on the market
CD HORIZON® Spinal System 54890005015 MEDTRONIC SOFAMOR DANEK, INC.	54890005015	00613994950642	Outer Diameter 5.0 mm; Length 15.0 mm	No longer on the market
CD HORIZON® Spinal System 54890005025 MEDTRONIC SOFAMOR DANEK, INC.	54890005025	00613994949776	Length 25.0 mm; Outer Diameter 5.0 mm	No longer on the market
CD HORIZON® Spinal System 54890005045 MEDTRONIC SOFAMOR DANEK, INC.	54890005045	00613994949974	Outer Diameter 5.0 mm; Length 45.0 mm	No longer on the market
CD HORIZON® Spinal System 54890005075 MEDTRONIC SOFAMOR DANEK, INC.	54890005075	00613994949912	Outer Diameter 5.0 mm; Length 75.0 mm	No longer on the market
CD HORIZON® Spinal System 54890005520 MEDTRONIC SOFAMOR DANEK, INC.	54890005520	00613994949899	Outer Diameter 5.5 mm; Length 20.0 mm	No longer on the market
CD HORIZON® Spinal System 54890005535 MEDTRONIC SOFAMOR DANEK, INC.	54890005535	00613994858177	Outer Diameter 5.5 mm; Length 35.0 mm	On the market
CD HORIZON® Spinal System 54890005550 MEDTRONIC SOFAMOR DANEK, INC.	54890005550	00613994858146	Length 50.0 mm; Outer Diameter 5.5 mm	On the market
CD HORIZON® Spinal System 54890005555 MEDTRONIC SOFAMOR DANEK, INC.	54890005555	00613994949882	Outer Diameter 5.5 mm; Length 55.0 mm	No longer on the market
CD HORIZON® Spinal System 54890006040 MEDTRONIC SOFAMOR DANEK, INC.	54890006040	00613994949783	Length 40.0 mm; Outer Diameter 6.0 mm	No longer on the market
CD HORIZON® Spinal System 54890006530 MEDTRONIC SOFAMOR DANEK, INC.	54890006530	00613994858139	Length 30.0 mm; Outer Diameter 6.5 mm	On the market
CD HORIZON® Spinal System 54890006565 MEDTRONIC SOFAMOR DANEK, INC.	54890006565	00613994949196	Length 65.0 mm; Outer Diameter 6.5 mm	No longer on the market
CD HORIZON® Spinal System 54890006580 MEDTRONIC SOFAMOR DANEK, INC.	54890006580	00613994949165	Length 80.0 mm; Outer Diameter 6.5 mm	No longer on the market
CD HORIZON® Spinal System 54890007511 MEDTRONIC SOFAMOR DANEK, INC.	54890007511	00613994950819	Length 110.0 mm; Outer Diameter 7.5 mm	No longer on the market
CD HORIZON® Spinal System 54890007545 MEDTRONIC SOFAMOR DANEK, INC.	54890007545	00613994858054	Length 45.0 mm; Outer Diameter 7.5 mm	On the market
CD HORIZON® Spinal System 54890007565 MEDTRONIC SOFAMOR DANEK, INC.	54890007565	00613994949462	Outer Diameter 7.5 mm; Length 65.0 mm	No longer on the market
CD HORIZON® Spinal System 54890007575 MEDTRONIC SOFAMOR DANEK, INC.	54890007575	00613994949448	Outer Diameter 7.5 mm; Length 75.0 mm	No longer on the market
CD HORIZON® Spinal System 54890008025 MEDTRONIC SOFAMOR DANEK, INC.	54890008025	00613994949417	Outer Diameter 8.0 mm; Length 25.0 mm	No longer on the market
CD HORIZON® Spinal System 54890008095 MEDTRONIC SOFAMOR DANEK, INC.	54890008095	00613994950949	Outer Diameter 8.0 mm; Length 95.0 mm	No longer on the market
CD HORIZON® Spinal System 54890008530 MEDTRONIC SOFAMOR DANEK, INC.	54890008530	00613994950888	Length 30.0 mm; Outer Diameter 8.5 mm	No longer on the market
CD HORIZON® Spinal System 54890009000 MEDTRONIC SOFAMOR DANEK, INC.	54890009000	00613994950284	Length 100.0 mm; Outer Diameter 9.0 mm	No longer on the market
CD HORIZON® Spinal System 54890009030 MEDTRONIC SOFAMOR DANEK, INC.	54890009030	00613994950239	Outer Diameter 9.0 mm; Length 30.0 mm	No longer on the market
CD HORIZON® Spinal System 54890009060 MEDTRONIC SOFAMOR DANEK, INC.	54890009060	00613994950178	Length 60.0 mm; Outer Diameter 9.0 mm	No longer on the market
CD HORIZON® Spinal System 54890009570 MEDTRONIC SOFAMOR DANEK, INC.	54890009570	00613994950420	Length 70.0 mm; Outer Diameter 9.5 mm	No longer on the market
CD HORIZON® Spinal System 54890009580 MEDTRONIC SOFAMOR DANEK, INC.	54890009580	00613994950406	Length 80.0 mm; Outer Diameter 9.5 mm	No longer on the market
CD HORIZON® Spinal System X0612564 MEDTRONIC SOFAMOR DANEK, INC.	X0612564	00643169270886	—	On the market
CD HORIZON® Spinal System X0612566 MEDTRONIC SOFAMOR DANEK, INC.	X0612566	00643169270909	—	On the market
CD HORIZON® Spinal System X0612576 MEDTRONIC SOFAMOR DANEK, INC.	X0612576	00643169271005	—	On the market
CD HORIZON® Spinal System X0612595 MEDTRONIC SOFAMOR DANEK, INC.	X0612595	00643169270756	—	On the market
CD HORIZON® Spinal System X0612603 MEDTRONIC SOFAMOR DANEK, INC.	X0612603	00643169270831	—	On the market
CD HORIZON® Spinal System X0612610 MEDTRONIC SOFAMOR DANEK, INC.	X0612610	00643169271340	—	On the market
CD HORIZON® Spinal System X0612637 MEDTRONIC SOFAMOR DANEK, INC.	X0612637	00643169271173	—	On the market
CD HORIZON® Spinal System X0612638 MEDTRONIC SOFAMOR DANEK, INC.	X0612638	00643169271180	—	On the market
CD HORIZON® Spinal System X0612641 MEDTRONIC SOFAMOR DANEK, INC.	X0612641	00643169271210	—	On the market
CD HORIZON® Spinal System X0612643 MEDTRONIC SOFAMOR DANEK, INC.	X0612643	00643169271234	—	On the market
CD HORIZON® Spinal System X0612645 MEDTRONIC SOFAMOR DANEK, INC.	X0612645	00643169271258	—	On the market
CD HORIZON® Spinal System X0612648 MEDTRONIC SOFAMOR DANEK, INC.	X0612648	00643169271289	—	On the market
CD HORIZON® Spinal System X0612650 MEDTRONIC SOFAMOR DANEK, INC.	X0612650	00643169271302	—	On the market
CD HORIZON® Spinal System X0612681 MEDTRONIC SOFAMOR DANEK, INC.	X0612681	00643169269835	Length 55.0 mm; Outer Diameter 8.5 mm	On the market
CD HORIZON® Spinal System X0612685 MEDTRONIC SOFAMOR DANEK, INC.	X0612685	00643169269873	Length 75.0 mm; Outer Diameter 8.5 mm	On the market
CD HORIZON® Spinal System X0612690 MEDTRONIC SOFAMOR DANEK, INC.	X0612690	00643169269927	Outer Diameter 8.5 mm; Length 100.0 mm	On the market
CD HORIZON® Spinal System X0612694 MEDTRONIC SOFAMOR DANEK, INC.	X0612694	00643169269965	Length 30.0 mm; Outer Diameter 9.0 mm	On the market
CD HORIZON® Spinal System X0612712 MEDTRONIC SOFAMOR DANEK, INC.	X0612712	00643169270589	Outer Diameter 9.5 mm; Length 30.0 mm	On the market
CD HORIZON® Spinal System X0612730 MEDTRONIC SOFAMOR DANEK, INC.	X0612730	00643169270329	Length 90.0 mm; Outer Diameter 10.0 mm	On the market
CD HORIZON® Spinal System X0612737 MEDTRONIC SOFAMOR DANEK, INC.	X0612737	00643169270398	Length 95.0 mm; Outer Diameter 10.5 mm	On the market

Other devices from Medtronic Sofamor Danek, Inc.

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See all devices from Medtronic Sofamor Danek, Inc. →

Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K112473

Other devices from Medtronic Sofamor Danek, Inc.

MSB Reusable Instruments 9870005

MSB CD HORIZON Spinal System 6530530

T2 STRATOSPHERE™ Expandable Corpectomy System 436125C

MSB SHILLA Growth Guidance System 7670431