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I-Bone

by Bonegraft Biomaterials Co. 154 variants

Ref SCRW-IPT30IS725, I-J10, SCRW-IBNCS4560, I-S6717, C-SCRW-IBS1572, SCRW-IPT30IS1030, I-G020410, I-PC3000, SCRW-IPT30IS820, I-G040715, I-PC030, PLT-I6HPE1625, C-PLT-I20HPS0515, C-SCRW-IBSE2815, PN-IBP15100, PN-IBP2760, I-F701104, PN-IBP2040, C-SCRW-IBSE292, PN-IBP1550, PN-IBP325, PN-IBP1540, I-PC075, I-BCAS0108, SCRW-IBNCS3520, I-S101020, C-EST-IFLD30-M, C-EST-IFLD30, I-PC100, SCRW-IPT30IS825, I-FPCS, IBONEKC-SV, SCRW-IBNCS3222, C-EST-IRLD25, C-SCRW-IBS2102, I-PKBF, I-P03, I-K353511, IBONEVC-LV-20, PN-IBP2025, SCRW-IBCS3220, I-K203011, C-PLT-I505010100515, SCRW-IPT30IS630, C-PLT-I8HSE0515, IBONEKC-LV-40, C-SCRW-IBS15410, PN-IBP2070, C-SCRW-IBSE2572, I-P01, C-PLT-ILPLS132

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-08681781338456 Basic UDI-DI Date15 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  • Withdrawn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

Device Name
I-bone® PLDLLA+TCP 30 Interference Screws Ø 7mm x 25mm
I – BONE β-TCP Gel Silicat 10 cc
I-Bone® Bioabsorbable Non-Cannulated Screw 4.5x60 mm
I – BONE β-TCP Flexible Silicat 6x7x17mm
I-Bone® Bioabsorbable Screw 1.5mm x 7mm (2 pcs)
I-bone® PLDLLA+TCP 30 Interference Screws Ø 10mm x 30mm
I – BONE β-TCP Crunch Silicat 2-4 mm - 10 cc
I – BONE Synthetic Bone Graft Putty Plus Crunch 30 cc
I-bone® PLDLLA+TCP 30 Interference Screws Ø 8mm x 20mm
I – BONE β-TCP Crunch Silicat 4-7 mm - 15 cc
I – BONE Synthetic Bone Graft Putty Plus Crunch 0,3 cc
I-Bone® 6-Hole Plate Extended t=1,6mm (for Ø2,5mm screws)
I-Bone® 20-Hole Plate, Straight t=0,50mm (for Ø1,5mm screws)
I-Bone® Bioabsorbable Screw 2.8mm x 15mm (EMG)
I-Bone® Bioabsorbable Pin 1.5mm x 100mm
I-Bone® Bioabsorbable Pin 2.7mm x 60mm
I – BONE β-TCP Flexible Silicat 70x110x4mm 30,00 cc
I-Bone® Bioabsorbable Pin 2.0mm x 40mm
I-Bone® Bioabsorbable Screw 2mm x 9mm (Emg.) (2 pcs)
I-Bone® Bioabsorbable Pin 1.5mm x 50mm
I-Bone® Bioabsorbable Pin 3mm x 25mm
I-Bone® Bioabsorbable Pin 1.5mm x 40mm
I – BONE Synthetic Bone Graft Putty Plus Crunch 0,75 cc
I-Bone Bone Cement Cavitation and Application Set (2 pcs of Filler and Pusher) Percutaneous Posterior Kyphoplasty, Cavity Creation Expander, Metal-Plastic
I-Bone® Bioabsorbable Non-Cannulated Screw 3.5x20 mm
I – BONE β-TCP Flexible Silicat 10x10x20mm
I-Bone® FOREHEAD Lift Mini Device 3,0MM
I-Bone® FOREHEAD Lift Device 3,0MM
I – BONE Synthetic Bone Graft Putty Plus Crunch 1 cc
I-bone® PLDLLA+TCP 30 Interference Screws Ø 8mm x 25mm
I-Bone Bone Filler and Pusher For Cannulated Screw(Short)
I-BONE SV Radiopaque Kyphoplasty Bone Cement, PMMA, 40g
I-Bone® Bioabsorbable Non-Cannulated Screw 3.2x22 mm
I-Bone® RIBBON Jowl and Neck Lift Device 2,5MM
I-Bone® Bioabsorbable Screw 2mm x 10mm (2 pcs)
I-Bone Percutaneous Posterior Kyphoplasty, Bone Filler, Metal-Plastic
I – BONE β-TCP Putty Silicat 3 cc
I - Bone Chondro Matrix 35-35-1,1mm
I-BONE LV Radiopaque Vertebroplasty Bone Cement, PMMA, 20g
I-Bone® Bioabsorbable Pin 2.0mm x 25mm
I-Bone® Bioabsorbable Cannulated Screw 3.2x20 mm
I - Bone Chondro Matrix 20-30-1,1mm
I-Bone® 50mm X 50mm 10x10 Hole t=0,50mm (for Ø1,5mm screws)
I-bone® PLDLLA+TCP 30 Interference Screws Ø 6mm x 30mm
I-Bone® 8-Hole Plate, Straight, Short t=0,50mm (for Ø1,5mm screws)
I-BONE LV Radiopaque Kyphoplasty Bone Cement, PMMA, 40g
I-Bone® Bioabsorbable Screw 1.5mm x 4mm (10 pcs)
I-Bone® Bioabsorbable Pin 2.0mm x 70mm
I-Bone® Bioabsorbable Screw 2.5mm x 7mm (2 pcs) (EMG)
I – BONE β-TCP Putty Silicat 1 cc
I-Bone® L Plate, Left Short t=1,3mm (for Ø2mm screws)
Model / Reference
SCRW-IPT30IS725, I-J10, SCRW-IBNCS4560, I-S6717, C-SCRW-IBS1572, SCRW-IPT30IS1030, I-G020410, I-PC3000, SCRW-IPT30IS820, I-G040715, I-PC030, PLT-I6HPE1625, C-PLT-I20HPS0515, C-SCRW-IBSE2815, PN-IBP15100, PN-IBP2760, I-F701104, PN-IBP2040, C-SCRW-IBSE292, PN-IBP1550, PN-IBP325, PN-IBP1540, I-PC075, I-BCAS0108, SCRW-IBNCS3520, I-S101020, C-EST-IFLD30-M, C-EST-IFLD30, I-PC100, SCRW-IPT30IS825, I-FPCS, IBONEKC-SV, SCRW-IBNCS3222, C-EST-IRLD25, C-SCRW-IBS2102, I-PKBF, I-P03, I-K353511, IBONEVC-LV-20, PN-IBP2025, SCRW-IBCS3220, I-K203011, C-PLT-I505010100515, SCRW-IPT30IS630, C-PLT-I8HSE0515, IBONEKC-LV-40, C-SCRW-IBS15410, PN-IBP2070, C-SCRW-IBSE2572, I-P01, C-PLT-ILPLS132
Primary DI / UDI-DI
08681781338456, 08681781319127, 08681781347199, 08681781318915, 08681781360570, 08681781338562, 08681781318748, 08681781319400, 08681781338470, 08681781318809, 08681781319295, 08681781350922, 08681781361072, 08681781360914, 08681781346727, 08681781346871, 08681781318960, 08681781346772, 08681781360693, 08681781346697, 08681781346895, 08681781346680, 08681781319325, 08681781334809, 08681781347113, 08681781318939, 08681781361294, 08681781361270, 08681781319332, 08681781338487, 08681781334823, 08681781333055, 08681781347090, 08681781361324, 08681781360709, 08681781334762, 08681781319059, 08681781332201, 08681781333000, 08681781346758, 08681781347250, 08681781332164, 08681781361102, 08681781338425, 08681781361065, 08681781333048, 08681781360525, 08681781346802, 08681781360822, 08681781319035, 08681781361164
Basic UDI-DI
B-08681781338456, B-08681781319127, B-08681781347199, B-08681781318915, B-08681781360570, B-08681781338562, B-08681781318748, B-08681781319400, B-08681781338470, B-08681781318809, B-08681781319295, B-08681781350922, B-08681781361072, B-08681781360914, B-08681781346727, B-08681781346871, B-08681781318960, B-08681781346772, B-08681781360693, B-08681781346697, B-08681781346895, B-08681781346680, B-08681781319325, B-08681781334809, B-08681781347113, B-08681781318939, B-08681781361294, B-08681781361270, B-08681781319332, B-08681781338487, B-08681781334823, B-08681781333055, B-08681781347090, B-08681781361324, B-08681781360709, B-08681781334762, B-08681781319059, B-08681781332201, B-08681781333000, B-08681781346758, B-08681781347250, B-08681781332164, B-08681781361102, B-08681781338425, B-08681781361065, B-08681781333048, B-08681781360525, B-08681781346802, B-08681781360822, B-08681781319035, B-08681781361164
EMDN Code
P09120605, P900402, P09120606, P099002, P900403
Device Class
Class III
Class IIa
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015715

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Properties

  • Sterile
  • Implantable YesEUDAMEDNoEUDAMED

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