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CD HORIZON® Spinal System X1010787

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

4 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 Number00613994953971 UDI-DI Date29 Jun 2015ListedStatusListed GUDID: 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  • Withdrawn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
X1010787
Primary DI / UDI-DI
00613994953971
510(k) Number
FDA Product Code
KWQ, MNH, MNI, KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 9.0 Millimeter
Length — 55.0 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

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