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CD HORIZON® Spinal System X0311313

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

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 Number00643169015296 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0465-2012 FDA Unclassified (pre-2012) initiated 30 Nov 2011
    • Terminated Z-0464-2012 FDA Unclassified (pre-2012) initiated 30 Nov 2011

    One screw may be longer then size etched on the screw.

  • 2 recalls, same reason

    • Terminated Z-2878-2011 FDA Unclassified (pre-2012) initiated 28 Jun 2011
    • Terminated Z-2875-2011 FDA Unclassified (pre-2012) initiated 28 Jun 2011

    Screws are longer then size etched on the screw.

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  • Withdrawn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
Spinal bone screw, non-bioabsorbable
Model / Reference
X0311313
Primary DI / UDI-DI
00643169015296
510(k) Number
FDA Product Code
MNH, KWQ, MNI, KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070, 888.3060, 888.3050
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 75.0 Millimeter

Related devices

Cleared under the same submission (K042025)

Show all (12)

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