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SteriSpine VA KITKYPHO10

by Imedicom Co., Ltd. EUDAMEDGUDID

Active European Union

Ref CAR-PIBE-40Model KITKYPHO10

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800038029323 Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800038029323 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MEDINAUT Plus, SteriSpine VA EUDAMED
SteriSpine VA GUDID
Generic Name
Balloon kyphoplasty kit
Device Name
Vertebral Augmentation System
Model / Reference
KITKYPHO10, CAR-PIBE-40
Primary DI / UDI-DI
08800038029323
Basic UDI-DI
B-08800038029323
510(k) Number
FDA Product Code
HRX, NDN, HXG
EMDN Code
K010301 Spinal percutaneous plastic devices with balloon
GMDN Term
Balloon kyphoplasty 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.

See all devices from Imedicom Co., Ltd. →

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