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CD HORIZON® Spinal System X0511038

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169001305 UDI-DI Date10 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CD HORIZON® Spinal System
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
X0511038
Primary DI / UDI-DI
00643169001305
FDA Product Code
MAX
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 36.0 Millimeter
Outer Diameter — 8.0 Millimeter

Related devices

Category: Metallic spinal interbody fusion cage

Other devices from Medtronic Sofamor Danek, Inc.

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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