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CD HORIZON® Spinal System RBT033302

by Medtronic Sofamor Danek, Inc.

Ref RBT033302

CD HORIZON® Spinal System RBT033302 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00763000011284), cleared under FDA 510(k) K182121 on 2 Nov 2018 and listed in FDA GUDID since 26 Jan 2019 (UDI-DI 00763000011284), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182121

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00763000011284 Basic UDI-DI 00763000011284UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000011284 UDI-DI Date26 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182121 Date2 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00763000011284 registered 23 Oct 2026 Active
  • FDA 510(k) K182121 decided 2 Nov 2018 Active
  • FDA GUDID UDI-DI 00763000011284 listed 26 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182121
  2. Listed FDA GUDID 00763000011284
  3. Registered EUDAMED B-00763000011284

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CD HORIZON® Spinal System
Generic name
Orthopaedic implant driver
Device name
Rg 5.5/6.0 Voyager Driver Long
Model / reference
RBT033302
Primary DI / UDI-DI
00763000011284
Basic UDI-DI
B-00763000011284
510(k) Number
FDA product code
OLO
EMDN code
L26 Surgical screwdrivers, reusable
GMDN term
Orthopaedic implant driver
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implant driver

Cleared under the same submission (K182121)

and 8 more cleared under K182121

Similar devices in this category

Other devices filed under SURGICAL SCREWDRIVERS, REUSABLE.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)