CD HORIZON® Spinal System 75445030

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 closed

Documents

None

No authorization documents

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	Number00885074133928 UDI-DI	Date18 Jun 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

2 recalls, same reason
- Terminated Z-0465-2012 FDA Unclassified (pre-2012) initiated 30 Nov 2011
- Terminated Z-0464-2012 FDA Unclassified (pre-2012) initiated 30 Nov 2011
One screw may be longer then size etched on the screw.
2 recalls, same reason
- Terminated Z-2878-2011 FDA Unclassified (pre-2012) initiated 28 Jun 2011
- Terminated Z-2875-2011 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Withdrawn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: 75445030
Description: SCREW 75445030 MULTI AXIAL 5.0X30 TI

Primary DI / UDI-DI: 00885074133928
510(k) Number: K042025
FDA Product Code: MNI, MNH, KWP, 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

Sterilization Method: Moist Heat or Steam Sterilization

Size: Outer Diameter — 5.0 Millimeter
Length — 30.0 Millimeter

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

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