CD HORIZON® Spinal System 54890001080

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number00613994950772 UDI-DI	Date29 Jun 2015Listed	StatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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Withdrawn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: 54890001080

Primary DI / UDI-DI: 00613994950772
510(k) Number: K112473
FDA Product Code: NKB, KWP, OSH, MNH, KWQ, MNI
GMDN Term: Spinal bone screw, non-bioabsorbable

Device Class: Class II
Regulation Number: 888.3070, 888.3050, 888.3060
GUDID distribution status: Not in Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 85.0 Millimeter
Outer Diameter — 10.0 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