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I-Bone

by Bonegraft Biomaterials Co. 154 variants

Ref C-SCRW-IBSE2517

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

The I-Bone Bioabsorbable Screw 2.5mm x 17mm (EMG) is a cutting-edge medical device designed for safe and effective bone grafting procedures. This innovative implant features a unique design, self-testing capabilities, and advanced biomaterials for optimal results.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681781360884 Basic UDI-DI 08681781360884UDI-DIDate16 Jan 2024RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
C-SCRW-IBSE2517
Primary DI / UDI-DI
08681781360884
Basic UDI-DI
B-08681781360884
EMDN Code
P09120606 Osteosynthesis devices, biodegradable screws and bars
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015715

Other devices from Bonegraft Biomaterials Co.

See all devices from Bonegraft Biomaterials Co. →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: 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