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SteriSpine VA SPICD-CA1/ SPICD-NDT1

by Imedicom Co., Ltd. EUDAMEDGUDID

Active European Union

Ref CAR-PIBE-40Model SPICD-CA1/ SPICD-NDT1

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800038039421 Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800038039421 UDI-DIDate24 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MEDINAUT Plus, SteriSpine VA EUDAMED
SteriSpine VA GUDID
Generic Name
Orthopaedic cement preparation/delivery kit
Device Name
Vertebral Augmentation System
Model / Reference
SPICD-CA1/ SPICD-NDT1, CAR-PIBE-40
Primary DI / UDI-DI
08800038039421
Basic UDI-DI
B-08800038039421
510(k) Number
FDA Product Code
HRX, NDN, HXG
EMDN Code
K010301 Spinal percutaneous plastic devices with balloon
GMDN Term
Orthopaedic cement preparation/delivery kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.1100, 888.3027, 888.4540
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K182287)

Show all (12)

Other devices from Imedicom Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No