CD HORIZON® Spinal System NAV2023

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

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	Number00643169347465 UDI-DI	Date4 Jul 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2363-2023 FDA Class II initiated 12 Jul 2023
Incorrect Laser Marking - Solera Awl Tip Tap

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: CD HORIZON® Spinal System
Generic Name: Surgical screwdriver, reusable
Model / Reference: NAV2023

Primary DI / UDI-DI: 00643169347465
510(k) Number: K140454
FDA Product Code: MNI, NKB, OSH, OLO, MNH, KWP, KWQ
GMDN Term: Surgical screwdriver, reusable

Device Class: Class II
Regulation Number: 888.3070, 882.4560, 888.3050, 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: 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