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CAPSTONE® Spinal System 2991222

by Medtronic Sofamor Danek, Inc.

Ref 2991222

CAPSTONE® Spinal System 2991222 is a device classified as Class IIb 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-00613994290960) and listed in FDA GUDID since 18 Aug 2015 (UDI-DI 00613994290960), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00613994290960 Basic UDI-DI 00613994290960UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613994290960 UDI-DI Date18 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00613994290960 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00613994290960 listed 18 Aug 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00613994290960
  2. Registered EUDAMED B-00613994290960

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
CAPSTONE® Spinal System
Generic name
Polymeric spinal interbody fusion cage
Model / reference
2991222
Primary DI / UDI-DI
00613994290960
Basic UDI-DI
B-00613994290960
FDA product code
MAX
EMDN code
P09070199 Spinal fusion systems - other
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 22.0 Millimeter
Outer Diameter — 12.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Polymeric spinal interbody fusion cage

Similar devices in this category

Other devices filed under SPINAL FUSION SYSTEMS - OTHER.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)