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MectaLIF 3D Metal Anterior 03.30.10.2164

by Medacta International

Ref 03.30.10.2164

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274VSR0011N00KB Basic UDI-DI 07630542786259UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630542786259 UDI-DI Date8 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
ALIF Inserter Oblique 15°-W35 EUDAMED
MectaLIF 3D Metal Anterior GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Spine Alignment guide / Insertion guide
Model / Reference
03.30.10.2164
Primary DI / UDI-DI
07630542786259
Basic UDI-DI
764014274VSR0011N00KB
Direct Marketing DI
07630542786259
510(k) Number
FDA Product Code
OVD
EMDN Code
L0922 Orthopaedic surgery guides, reusable
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3080
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K254202)

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Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No