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Hps™ 2.0

by Paradigm Spine GmbH Germany EUDAMED

Ref HBI44535Model HPS™ 2.0 Polyaxial pedicle screw, MIS

EMDN P09070302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04260636670497 Basic UDI-DIDate3 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HPS™ 2.0 Polyaxial pedicle screw, MIS Ø4.5 x 35mm
Model / Reference
HPS™ 2.0 Polyaxial pedicle screw, MIS, HBI44535
Primary DI / UDI-DI
04260636670497
Basic UDI-DI
B-04260636670497
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000011231

Other devices from Paradigm Spine GmbH

See all devices from Paradigm Spine GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 32c79f0c-4d4a-4755-a49a-4b5b26da6ddf 61 fields · synced 24 Oct 2026