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CD HORIZON® Spinal System X0606044

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994218629 UDI-DI Date16 Jul 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2874-2011 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  • Withdrawn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
X0606044
Primary DI / UDI-DI
00613994218629
510(k) Number
FDA Product Code
KWP, KWQ, MNH, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050, 888.3060, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 65.0 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K031655)

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