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Spine Instruments 03.52.10.0114

by Medacta International

Ref 03.52.10.0114

Spine Instruments 03.52.10.0114 is a device classified as Class IIa in the EU and Class I in the US made by Medacta International, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-07630971203402) and listed in FDA GUDID since 6 Aug 2020 (UDI-DI 07630971203402), 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-07630971203402 Basic UDI-DI 07630971203402UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630971203402 UDI-DI Date6 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07630971203402 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 07630971203402 listed 6 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630971203402
  2. Registered EUDAMED B-07630971203402

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  • Withdrawn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
MIS Blade 80mm EUDAMED
Spine Instruments GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Spine Retractor blade
Model / reference
03.52.10.0114
Primary DI / UDI-DI
07630971203402
Basic UDI-DI
B-07630971203402
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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 I

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

Related devices

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

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Medacta International

See all devices from Medacta International →

Properties

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