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Spineorth

by Bonegraft Biomaterials Co. 2 variants

Ref SBCGC, SBCAFP2, SBCGW, SVBIS, SBCAS0108, SBCVPK0108, SPFPCS, SBCGN, SBCBD, SPKBF

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681781350014 Basic UDI-DI Date5 Feb 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  • Withdrawn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

Device Name
Spineorth Bone Cement Applicator Guide Cannula
Spineorth Bone Cement Applicator Filler and Pusher For Vertebroplasty
Spineorth Bone Cement Applicator Guide Wire (Kirschner wire)
Spineorth Vertebroplasty, Percutaneous Posterior, Vertebroplasty Bone Interference Set, Metal-Plastic
Spineorth Bone Cement Cavitation and Application Set (2 pcs of Filler and Pusher) Percutaneous Posterior Kyphoplasty, Cavity Creation Expander, Metal-Plastic
Spineorth Bone Cement Vertebroplasty, Percutaneous Posterior, Vertebroplasty Kit (2pcs Filler+ 2 pcs Pusher)
Spineorth Bone Filler and Pusher For Cannulated Screw(Short)
Spineorth Bone Cement Applicator Gauge Needle (Awl)
Spineorth Bone Cement Bone Drill
Spineorth Percutaneous Posterior Kyphoplasty, Bone Filler, Metal-Plastic
Model / Reference
SBCGC, SBCAFP2, SBCGW, SVBIS, SBCAS0108, SBCVPK0108, SPFPCS, SBCGN, SBCBD, SPKBF
Primary DI / UDI-DI
08681781350014, 08681781350069, 08681781350007, 08681781350038, 08681781350090, 08681781350083, 08681781350113, 08681781350021, 08681781350045, 08681781350052
Basic UDI-DI
B-08681781350014, B-08681781350069, B-08681781350007, B-08681781350038, B-08681781350090, B-08681781350083, B-08681781350113, B-08681781350021, B-08681781350045, B-08681781350052
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
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

Other properties (12)

  • Implantable: No
  • 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