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Osteon

by Bonegraft Biomaterials Co. 158 variants

Ref SCRW-OBCS4570, OSC820, SCRW-OPIS725, OW082530, OCS0407151, C-SCRW-OBS2152, OK253511, OG10002050, OCS10002201, OPC3000, C-PLT-OLPLS132, OK203011, OPC1000, SCRW-OPT30IS925, PN-OBP1530, SCRW-OBCS3528, SCRW-OPT30IS935, C-EST-OFLD30, OCS0307076, C-SCRW-OBS1544, OK202020, OGR020430, PN-OBP1570, C-PLT-O8HSE0515, OK202011, C-PLT-OYP132, SCRW-OBCS3222, OSBCGN, C-SCRW-OBSE2511, OCS0407101, C-SCRW-OBSE2817, OCS0307051, PN-OBP2320, C-PLT-OHPC0515, ODP050, OG02501010, C-PLT-OTP0515, OG040705, PLT-O4HP1625, OP03, SCRW-OBCS3216, PN-OBP325, C-PLT-O219HPS115, OCS05001151, OF25505, ODP100, C-SCRW-OBSE2813, OW101520, OG020420, C-PLT-O505010100515, FN-OBCFS1216

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-08681781348127 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  • Withdrawn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
Osteon® Bioabsorbable Cannulated Screw 4.5x70 mm
Osteon Crunch (Stick) 8x20mm 5,19 cc
Osteon® PLA Interference Screws Ø 7mm x 25mm
Osteon Crunch (Stick) 8x25x30mm 7,65 cc
Osteon β-TCP Crunch Silicat Add. 4-7 mm - 15,10 cc
Osteon® Bioabsorbable Screw 2mm x 15mm (2 pcs)
Osteon Chondro Matrix 25-35-1,1mm
Osteon Granule (Crunch) 1-2 mm - 5 cc
Osteon β-TCP Crunch Silicat Add. 1-2 mm - 20,10 cc
Osteon Synthetic Bone Graft Putty Plus Crunch 30 cc
Osteon® L Plate, Left Short t=1,3mm (for Ø2mm screws)
Osteon Chondro Matrix 20-30-1,1mm
Osteon Synthetic Bone Graft Putty Plus Crunch 10 cc
Osteon® PLDLLA+TCP 30 Interference Screws Ø 9mm x 25mm
Osteon® Bioabsorbable Pin 1.5mm x 30mm
Osteon® Bioabsorbable Cannulated Screw 3.5x28 mm
Osteon® PLDLLA+TCP 30 Interference Screws Ø 9mm x 35mm
Osteon® FOREHEAD Lift Device 3,0MM
Osteon β-TCP Crunch Silicat Add. 3-7 mm - 7,60 cc
Osteon® Bioabsorbable Screw 1.5mm x 4mm (4 pcs)
Osteon Chondro Matrix 20-20-2,0mm
Osteon β-TCP Crunch Silicat Radiopaque 2-4 mm - 30 cc
Osteon® Bioabsorbable Pin 1.5mm x 70mm
Osteon® 8-Hole Plate, Straight, Short t=0,50mm (for Ø1,5mm screws)
Osteon Chondro Matrix 20-20-1,1mm
Osteon® Y Plate t=1,3mm (for Ø2mm screws)
Osteon® Bioabsorbable Cannulated Screw 3.2x22 mm
Osteon Bone Cement Applicator Gauge Needle (Awl)
Osteon® Bioabsorbable Screw 2.5mm x 11mm (EMG)
Osteon β-TCP Crunch Silicat Add. 4-7 mm - 10,10 cc
Osteon® Bioabsorbable Screw 2.8mm x 17mm (EMG)
Osteon β-TCP Crunch Silicat Add. 3-7 mm - 5,10 cc
Osteon® Bioabsorbable Pin 2.3mm x 20mm
Osteon® 6-Hole Plate, Curved t=0,50mm (for Ø1,5mm screws)
Osteon Synthetic Bone Graft Dental Putty 0,5 cc
Osteon Granule (Crunch) 0.25-1 mm - 1 cc
Osteon® T Plate t=0,50mm (for Ø1,5mm screws)
Osteon Granule (Crunch) 4-7 mm - 5 cc
Osteon® 4-Hole Plate t=1,6mm (for Ø2,5mm screws)
Osteon Putty 3 cc
Osteon® Bioabsorbable Cannulated Screw 3.2x16 mm
Osteon® Bioabsorbable Pin 3mm x 25mm
Osteon® 2x19-Hole Plate, Straight t=1 mm (for Ø1,5mm screws)
Osteon β-TCP Crunch Silicat Add. 0.5-1 mm - 15,10 cc
Osteon β-TCP Flexible Silicat Radiopaque 25x50x5mm6,25 cc
Osteon Synthetic Bone Graft Dental Putty 1 cc
Osteon® Bioabsorbable Screw 2.8mm x 13mm (EMG)
Osteon Crunch (Stick) 10x15x20mm 3,44 cc
Osteon Granule (Crunch) 2-4 mm - 20 cc
Osteon® 50mm X 50mm 10x10 Hole t=0,50mm (for Ø1,5mm screws)
Osteon® Bioabsorbable Compression Fusion Screw Ø12 x 16 mm
Model / Reference
SCRW-OBCS4570, OSC820, SCRW-OPIS725, OW082530, OCS0407151, C-SCRW-OBS2152, OK253511, OG10002050, OCS10002201, OPC3000, C-PLT-OLPLS132, OK203011, OPC1000, SCRW-OPT30IS925, PN-OBP1530, SCRW-OBCS3528, SCRW-OPT30IS935, C-EST-OFLD30, OCS0307076, C-SCRW-OBS1544, OK202020, OGR020430, PN-OBP1570, C-PLT-O8HSE0515, OK202011, C-PLT-OYP132, SCRW-OBCS3222, OSBCGN, C-SCRW-OBSE2511, OCS0407101, C-SCRW-OBSE2817, OCS0307051, PN-OBP2320, C-PLT-OHPC0515, ODP050, OG02501010, C-PLT-OTP0515, OG040705, PLT-O4HP1625, OP03, SCRW-OBCS3216, PN-OBP325, C-PLT-O219HPS115, OCS05001151, OF25505, ODP100, C-SCRW-OBSE2813, OW101520, OG020420, C-PLT-O505010100515, FN-OBCFS1216
Primary DI / UDI-DI
08681781348127, 08681781320185, 08681781339019, 08681781320222, 08681781320994, 08681781361669, 08681781332096, 08681781319929, 08681781320802, 08681781321168, 08681781362055, 08681781332065, 08681781321137, 08681781338906, 08681781347427, 08681781348059, 08681781338920, 08681781362161, 08681781320925, 08681781361409, 08681781332119, 08681781320550, 08681781347465, 08681781361959, 08681781332058, 08681781362086, 08681781348011, 08681781334854, 08681781361744, 08681781320987, 08681781361812, 08681781320918, 08681781347571, 08681781361850, 08681781320680, 08681781319868, 08681781361867, 08681781320055, 08681781350984, 08681781320321, 08681781347984, 08681781347649, 08681781361973, 08681781320741, 08681781320444, 08681781320703, 08681781361799, 08681781320277, 08681781319981, 08681781361997, 08681781347755
Basic UDI-DI
B-08681781348127, B-08681781320185, B-08681781339019, B-08681781320222, B-08681781320994, B-08681781361669, B-08681781332096, B-08681781319929, B-08681781320802, B-08681781321168, B-08681781362055, B-08681781332065, B-08681781321137, B-08681781338906, B-08681781347427, B-08681781348059, B-08681781338920, B-08681781362161, B-08681781320925, B-08681781361409, B-08681781332119, B-08681781320550, B-08681781347465, B-08681781361959, B-08681781332058, B-08681781362086, B-08681781348011, B-08681781334854, B-08681781361744, B-08681781320987, B-08681781361812, B-08681781320918, B-08681781347571, B-08681781361850, B-08681781320680, B-08681781319868, B-08681781361867, B-08681781320055, B-08681781350984, B-08681781320321, B-08681781347984, B-08681781347649, B-08681781361973, B-08681781320741, B-08681781320444, B-08681781320703, B-08681781361799, B-08681781320277, B-08681781319981, B-08681781361997, B-08681781347755
EMDN Code
P09120606, P900402, P09120605, P099002
Device Class
Class III
Class IIa
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