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CD HORIZON® Spinal System 55410006060

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169140844 UDI-DI Date17 Jun 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2603-2018 FDA Class II initiated 9 Jul 2018

    This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

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  • Withdrawn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
55410006060
Primary DI / UDI-DI
00643169140844
510(k) Number
FDA Product Code
NKB, KWP, OSH, MNH, KWQ, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6.0 Millimeter
Length — 60.0 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K113174)

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