CD HORIZON® Spinal System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: CD HORIZON® Spinal System FDA UDI
Generic Name: Orthopaedic trocar blade, reusable FDA UDI
Device Name: MOD LEGACY NARROW BLADE HK FDA UDI
Model / Reference: X0802220 FDA UDI
Description: MOD LEGACY NARROW BLADE HK FDA UDI

Identifiers

Primary DI / UDI-DI: 00721902659799 FDA UDI
510(k) Number: K970599 FDA UDI
FDA Product Code: MNI FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term: Orthopaedic trocar blade, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic trocar blade, reusable

CD HORIZON® Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic trocar blade, reusable.

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Cleared under the same submission

K970599 also covers:

CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI a8278b5c-44ce-4650-b460-3b03a8992012 35 fields · synced May 30, 2026