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Spine Instruments 03.65.10.0055

by Medacta International

Ref 03.65.10.0055

Spine Instruments 03.65.10.0055 is a Class I device made by Medacta International, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI 764014274VSR0151N00M4) and listed in FDA GUDID since 2 Dec 2020 (UDI-DI 07630971213494), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274VSR0151N00M4 Basic UDI-DI 07630971213494UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630971213494 UDI-DI Date2 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274VSR0151N00M4 registered 17 Jun 2026 Active
  • FDA GUDID UDI-DI 07630971213494 listed 2 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630971213494
  2. Registered EUDAMED 764014274VSR0151N00M4

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  • Withdrawn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

Trade name
Screw extractor EUDAMED
Spine Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Spine Extraction instrument / Removal device / Corkscrew
Model / reference
03.65.10.0055
Primary DI / UDI-DI
07630971213494
Basic UDI-DI
764014274VSR0151N00M4
Direct marketing DI
07630971213494
FDA product code
LXH
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Similar devices in this category

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

Other devices from Medacta International

See all devices from Medacta International →

Properties

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