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3650114

by Medtronic Sofamor Danek, Inc.

Ref 3650114

3650114 is a Class I device made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0763000B00032307N) and listed in FDA GUDID since 27 Mar 2026 (UDI-DI 00199150024896), active as of 7 Nov 2026.

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

CE MDR

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/MDR EUDAMED Number0763000B00032307N Basic UDI-DI 00199150024896UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150024896 UDI-DI Date27 Mar 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00032307N registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00199150024896 listed 27 Mar 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00199150024896
  2. Registered EUDAMED 0763000B00032307N

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Set Screw driver
Model / reference
3650114
Primary DI / UDI-DI
00199150024896
Basic UDI-DI
0763000B00032307N
FDA product code
HXX
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)