Powerbone
by Bonegraft Biomaterials Co. 318 variants
Ref C-SCRW-PBS1534, PFSS5617, PG020410, PM2030-5, SCRW-PBBCS4590, PLT-PB4HP1625, PG030510, PFSW081520, PPC1000, PDP100, PFSS6734, PKC-LV-20, C-EST-PRLDS, PCS10002201, PFS251002, PS1010402, PCS55205, PVC-LV-20, PPS075, C-PLT-P10010020200515, PSC5204, PCS05001151, SCRW-PBBNCS4560, PFS35605, PM1520, PFSC5204, PG040730, PCS55256, C-SCRW-PBS1582, PS4440, C-PLT-PLPL132, PBK353511, PFS25506, PCS0204075, PPS08, PG10002051, SCRW-PBBNCS4580, SCRW-PPT30IS625, PG040705, C-EST-PMLDS, PFSS6717, C-PLT-P6HPCS132, C-EST-PRLD25, SCRW-PPIS730, PFSC4204, PG10002200, PG05001010, PM2030, C-PLT-PXPS132, C-SCRW-PBS1542, PSC420
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-08681781354258 | Date16 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- Withdrawn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
- Powerbone® Bioabsorbable Screw 1.5mm x 3mm (4 pcs)Powerbone β-TCP Flexible Silicat Add. 5x6x17mmPowerbone Granule (Crunch) 2-4 mm - 10 ccPowerbone Barrier Membrane 20x30 (5pcs)Powerbone® Bioabsorbable Cannulated Screw 4.5x90 mmPowerbone® 4-Hole Plate t=1,6mm (for Ø2,5mm screws)Powerbone Granule (Crunch) 3-5 mm - 10 ccPowerbone β-TCP Flexible Silicat Add. 8x15x20mmPowerbone Synthetic Bone Graft Putty Plus Crunch 10 ccPowerbone Synthetic Bone Graft Dental Putty 1 ccPowerbone β-TCP Flexible Silicat Add. 6x7x34mmPowerbone LV Radiopaque Kyphoplasty Bone Cement, PMMA, 20gPowerbone® RIBBON Jowl and Neck Lift Device ShortPowerbone β-TCP Crunch Silicat Add. 1-2 mm - 20,10 ccPowerbone β-TCP Flexible Silicat Add. 25x100x2mmPowerbone Crunch (Stick) 10x10x40mm (2pcs) 19,90 ccPowerbone β-TCP Crunch Silicat Add. 5x5x20mm (5pcs)Powerbone LV Radiopaque Vertebroplasty Bone Cement, PMMA, 20gPowerbone β-TCP Putty Silicat Add. 7,5 ccPowerbone® 100mm X 100mm 20x20 Hole t=0,50mm (for Ø1,5mm screws)Powerbone Crunch (Stick) 5x20mm (4pcs) 12,96 ccPowerbone β-TCP Crunch Silicat Add. 0.5-1 mm - 15,10 ccPowerbone® Bioabsorbable Non-Cannulated Screw 4.5x60 mmPowerbone β-TCP Flexible Silicat Add. 35x60x5mm 10,50 ccPowerbone Barrier Membrane 15x20Powerbone β-TCP Flexible Silicat Add. 5x20mm (4pcs)Powerbone Granule (Crunch) 4-7 mm - 30 ccPowerbone β-TCP Crunch Silicat Add. 5x5x25mm (6pcs)Powerbone® Bioabsorbable Screw 1.5mm x 8mm (2 pcs)Powerbone Crunch (Stick) 4x4x40mm 4,05 ccPowerbone® L Plate, Left t=1,3mm (for Ø2mm screws)Powerbone Chondro Matrix 35-35-1,1mmPowerbone β-TCP Flexible Silicat Add. 25x50x6mm 7,50 ccPowerbone β-TCP Crunch Silicat Add. 2-4 mm - 7,50 ccPowerbone β-TCP Putty Silicat Add. 8 ccPowerbone Granule (Crunch) 1,2 mm - 5,10 ccPowerbone® Bioabsorbable Non-Cannulated Screw 4.5x80 mmPowerbone® PLDLLA+TCP 30 Interference Screws Ø 6mm x 25mmPowerbone Granule (Crunch) 4-7 mm - 5 ccPowerbone® MIDFACE Lift Device ShortPowerbone β-TCP Flexible Silicat Add. 6x7x17mmPowerbone® 6-Hole Plate Curved Short t=1,3mm (for Ø2mm screws)Powerbone® RIBBON Jowl and Neck Lift Device 2,5MMPowerbone® PLA Interference Screws Ø 7mm x 30mmPowerbone β-TCP Flexible Silicat Add. 4x20mm (4pcs)Powerbone Granule (Crunch) 1-2 mm - 20 ccPowerbone Granule (Crunch) 0.5-1 mm - 1 ccPowerbone Barrier Membrane 20x30Powerbone® X Plate, Short t=1,3mm (for Ø2mm screws)Powerbone® Bioabsorbable Screw 1.5mm x 4mm (2 pcs)Powerbone Crunch (Stick) 4x20mm 2,60 cc
- Model / Reference
- C-SCRW-PBS1534, PFSS5617, PG020410, PM2030-5, SCRW-PBBCS4590, PLT-PB4HP1625, PG030510, PFSW081520, PPC1000, PDP100, PFSS6734, PKC-LV-20, C-EST-PRLDS, PCS10002201, PFS251002, PS1010402, PCS55205, PVC-LV-20, PPS075, C-PLT-P10010020200515, PSC5204, PCS05001151, SCRW-PBBNCS4560, PFS35605, PM1520, PFSC5204, PG040730, PCS55256, C-SCRW-PBS1582, PS4440, C-PLT-PLPL132, PBK353511, PFS25506, PCS0204075, PPS08, PG10002051, SCRW-PBBNCS4580, SCRW-PPT30IS625, PG040705, C-EST-PMLDS, PFSS6717, C-PLT-P6HPCS132, C-EST-PRLD25, SCRW-PPIS730, PFSC4204, PG10002200, PG05001010, PM2030, C-PLT-PXPS132, C-SCRW-PBS1542, PSC420
- Primary DI / UDI-DI
- 08681781354258, 08681781304093, 08681781300125, 08681781331303, 08681781342149, 08681781350267, 08681781300170, 08681781304383, 08681781325531, 08681781303218, 08681781304123, 08681781332508, 08681781355125, 08681781325128, 08681781325432, 08681781302860, 08681781303812, 08681781332478, 08681781304802, 08681781354869, 08681781300576, 08681781325067, 08681781341944, 08681781304703, 08681781303034, 08681781304291, 08681781300255, 08681781303850, 08681781354357, 08681781302747, 08681781354913, 08681781331501, 08681781304451, 08681781303553, 08681781304819, 08681781324787, 08681781341968, 08681781335752, 08681781300217, 08681781355118, 08681781304116, 08681781354999, 08681781355095, 08681781335981, 08681781304284, 08681781302570, 08681781300040, 08681781303072, 08681781354951, 08681781354272, 08681781300514
- Basic UDI-DI
- B-08681781354258, B-08681781304093, B-08681781300125, B-08681781331303, B-08681781342149, B-08681781350267, B-08681781300170, B-08681781304383, B-08681781325531, B-08681781303218, B-08681781304123, B-08681781332508, B-08681781355125, B-08681781325128, B-08681781325432, B-08681781302860, B-08681781303812, B-08681781332478, B-08681781304802, B-08681781354869, B-08681781300576, B-08681781325067, B-08681781341944, B-08681781304703, B-08681781303034, B-08681781304291, B-08681781300255, B-08681781303850, B-08681781354357, B-08681781302747, B-08681781354913, B-08681781331501, B-08681781304451, B-08681781303553, B-08681781304819, B-08681781324787, B-08681781341968, B-08681781335752, B-08681781300217, B-08681781355118, B-08681781304116, B-08681781354999, B-08681781355095, B-08681781335981, B-08681781304284, B-08681781302570, B-08681781300040, B-08681781303072, B-08681781354951, B-08681781354272, B-08681781300514
- EMDN Code
- P09120606, P900402, Q010301, P900403, P09120605
- Device Class
- Class IIIClass 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