Skip to content

Spine Instruments 03.52.10.0207

by Medacta International SA

Ref 03.52.10.0207

Spine Instruments 03.52.10.0207 is a Class I device made by Medacta International SA, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 764014274VSR0410N00LQ) and listed in FDA GUDID since 14 Oct 2020 (UDI-DI 07630971203877), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274VSR0410N00LQ Basic UDI-DI 07630971203877UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630971203877 UDI-DI Date14 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764014274VSR0410N00LQ registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 07630971203877 listed 14 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630971203877
  2. Registered EUDAMED 764014274VSR0410N00LQ

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  • Withdrawn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
MIS T-Handle EUDAMED
Spine Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Spine Retractor / Retracting blade
Model / reference
03.52.10.0207
Primary DI / UDI-DI
07630971203877
Basic UDI-DI
764014274VSR0410N00LQ
Direct marketing DI
07630971203877
FDA product code
LXH
EMDN code
L0915 Spreaders and retractors for orthopaedic surgery, 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 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)