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
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08681781338456 | Date15 Jan 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- I-bone® PLDLLA+TCP 30 Interference Screws Ø 7mm x 25mmI – BONE β-TCP Gel Silicat 10 ccI-Bone® Bioabsorbable Non-Cannulated Screw 4.5x60 mmI – BONE β-TCP Flexible Silicat 6x7x17mmI-Bone® Bioabsorbable Screw 1.5mm x 7mm (2 pcs)I-bone® PLDLLA+TCP 30 Interference Screws Ø 10mm x 30mmI – BONE β-TCP Crunch Silicat 2-4 mm - 10 ccI – BONE Synthetic Bone Graft Putty Plus Crunch 30 ccI-bone® PLDLLA+TCP 30 Interference Screws Ø 8mm x 20mmI – BONE β-TCP Crunch Silicat 4-7 mm - 15 ccI – BONE Synthetic Bone Graft Putty Plus Crunch 0,3 ccI-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 100mmI-Bone® Bioabsorbable Pin 2.7mm x 60mmI – BONE β-TCP Flexible Silicat 70x110x4mm 30,00 ccI-Bone® Bioabsorbable Pin 2.0mm x 40mmI-Bone® Bioabsorbable Screw 2mm x 9mm (Emg.) (2 pcs)I-Bone® Bioabsorbable Pin 1.5mm x 50mmI-Bone® Bioabsorbable Pin 3mm x 25mmI-Bone® Bioabsorbable Pin 1.5mm x 40mmI – BONE Synthetic Bone Graft Putty Plus Crunch 0,75 ccI-Bone Bone Cement Cavitation and Application Set (2 pcs of Filler and Pusher) Percutaneous Posterior Kyphoplasty, Cavity Creation Expander, Metal-PlasticI-Bone® Bioabsorbable Non-Cannulated Screw 3.5x20 mmI – BONE β-TCP Flexible Silicat 10x10x20mmI-Bone® FOREHEAD Lift Mini Device 3,0MMI-Bone® FOREHEAD Lift Device 3,0MMI – BONE Synthetic Bone Graft Putty Plus Crunch 1 ccI-bone® PLDLLA+TCP 30 Interference Screws Ø 8mm x 25mmI-Bone Bone Filler and Pusher For Cannulated Screw(Short)I-BONE SV Radiopaque Kyphoplasty Bone Cement, PMMA, 40gI-Bone® Bioabsorbable Non-Cannulated Screw 3.2x22 mmI-Bone® RIBBON Jowl and Neck Lift Device 2,5MMI-Bone® Bioabsorbable Screw 2mm x 10mm (2 pcs)I-Bone Percutaneous Posterior Kyphoplasty, Bone Filler, Metal-PlasticI – BONE β-TCP Putty Silicat 3 ccI - Bone Chondro Matrix 35-35-1,1mmI-BONE LV Radiopaque Vertebroplasty Bone Cement, PMMA, 20gI-Bone® Bioabsorbable Pin 2.0mm x 25mmI-Bone® Bioabsorbable Cannulated Screw 3.2x20 mmI - Bone Chondro Matrix 20-30-1,1mmI-Bone® 50mm X 50mm 10x10 Hole t=0,50mm (for Ø1,5mm screws)I-bone® PLDLLA+TCP 30 Interference Screws Ø 6mm x 30mmI-Bone® 8-Hole Plate, Straight, Short t=0,50mm (for Ø1,5mm screws)I-BONE LV Radiopaque Kyphoplasty Bone Cement, PMMA, 40gI-Bone® Bioabsorbable Screw 1.5mm x 4mm (10 pcs)I-Bone® Bioabsorbable Pin 2.0mm x 70mmI-Bone® Bioabsorbable Screw 2.5mm x 7mm (2 pcs) (EMG)I – BONE β-TCP Putty Silicat 1 ccI-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 IIIClass IIaClass IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000015715
Other devices from Bonegraft Biomaterials Co.
Properties
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