CD HORIZON® Spinal System X0411239

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00643169006492 UDI-DI	Date25 Jun 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-2874-2011 FDA Unclassified (pre-2012) initiated 28 Jun 2011
Screws are longer then size etched on the screw.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: CD HORIZON® Spinal System
Generic Name: Spinal bone screw, non-bioabsorbable
Model / Reference: X0411239

Primary DI / UDI-DI: 00643169006492
510(k) Number: K031655
FDA Product Code: KWP, MNI, MNH, KWQ
GMDN Term: Spinal bone screw, non-bioabsorbable

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

Size: Outer Diameter — 6.5 Millimeter
Length — 95.0 Millimeter

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (9)

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