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Vantage® Total Ankle

by Exactech, Inc. EUDAMED

Active European Union

Ref 350-02-05EModel Vantage

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number10885862100047P2 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 777490 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    3 Sep 2026
    Expires
    2 Sep 2031

Specification

EUDAMED

Device Name
Mobile Bearing
Model / Reference
Vantage, 350-02-05E
Primary DI / UDI-DI
10885862530868
Basic UDI-DI
10885862100047P2
EMDN Code
P0905060202 Ankle prostheses with uncemented mobile insert - talar components
Device Class
Class III
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000017730
Authorised representative
Blue Ortho SAS FR-AR-000005249

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterile
  • Implantable
  • CMR Substance

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No