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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 prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
CAP 99465135 THREADED NUT CAP SI FDA UDI
Model / Reference
99465135 FDA UDI
Description
CAP 99465135 THREADED NUT CAP SI FDA UDI

Identifiers

Primary DI / UDI-DI
20613994170174 FDA UDI
510(k) Number
K062606 FDA UDI
FDA Product Code
NKB FDA UDI
KWQ FDA UDI
NQP FDA UDI
KWF FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
888.3230 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 7640520f-fd60-4a32-abf5-0e20434cc3ac 35 fields · synced May 30, 2026