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CD HORIZON® Spinal System 5563250

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00643169227798 UDI-DI Date15 Jun 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Bone-screw internal spinal fixation system connector
Model / Reference
5563250
Primary DI / UDI-DI
00643169227798
510(k) Number
FDA Product Code
OSH, MNI, MNH, KWQ, NKB, KWP
GMDN Term
Bone-screw internal spinal fixation system connector
Device Class
Class II
Regulation Number
888.3070, 888.3060, 888.3050
GUDID distribution status
In Commercial Distribution
Size
Length — 50.0 Millimeter
Circumference — 6.0 Millimeter

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • 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