CD HORIZON® Spinal System 55840005590

by Medtronic Sofamor Danek, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00613994971692 UDI-DI	Date29 Jun 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESU from GUDID Special	NumberK113174	Date21 Nov 2011Decided	StatusActive

Recalls

1 recall · FDA

- Terminated Z-2603-2018 FDA Class II initiated 9 Jul 2018
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CD HORIZON® Spinal System
Generic name: Spinal bone screw, non-bioabsorbable
Model / reference: 55840005590

Primary DI / UDI-DI: 00613994971692
510(k) Number: K113174
FDA product code: MNH, OSH, KWP, MNI, NKB, KWQ
GMDN term: Spinal bone screw, non-bioabsorbable

Device class: Class II
Regulation number: 888.3070, 888.3050, 888.3060
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Length — 90.0 Millimeter
Outer Diameter — 5.5 Millimeter

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10)

Supplied sterile: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No