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fX

by Bonegraft Biomaterials Co. 98 variants

Ref SCRW-FXPT30IS725, fXBCAS0108, PN-FXBP340, SCRW-FXPIS930, SCRW-FXBCS4560, C-PLT-FX219HPS115, fXKC-SV, C-PLT-FX6HPCS132, SCRW-FXPT30IS1035, SCRW-FXBCS4550, C-SCRW-FXBSE2811, C-SCRW-FXBS1544, C-PLT-FX505010100515, PN-FXBP1720, SCRW-FXBNCS3536, SCRW-FXBNCS3520, SCRW-FXPT30IS23410, PN-FXBP640, SCRW-FXBCS4570, SCRW-FXBCS3536, PN-FXBP3250, C-PLT-FX10HP1625, PN-FXBP550, C-PLT-FX8HP1625, C-SCRW-FXBSE2515, SCRW-FXPT30IS1125, PN-FXBP660, FN-FXBCFS1216, C-PLT-FXTP0515, SCRW-FXBNCS4590, C-PLT-FXLPLS132, C-PLT-FX4HP1625, SCRW-FXBNCS3220, C-PLT-FX4HPS132, C-SCRW-FXBS242, SCRW-FXPT30IS623, SCRW-FXBCS3220, C-SCRW-FXBS282, SCRW-FXPT30IS1025, PN-FXBP2025, PN-FXBP3260, SCRW-FXBNCS3224, C-SCRW-FXBSE292, C-SCRW-FXBS2152, C-PLT-FXXPE0515, C-SCRW-FXBS15410, SCRW-FXBNCS4570, C-PLT-FXYP132, SCRW-FXPT30IS1135, SCRW-FXBCS3532, C-PLT-FX6HPSE0515

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-08681781339590 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  • Withdrawn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
fX® PLDLLA+TCP 30 Interference Screws Ø 7mm x 25mm
fX Bone Cement Cavitation and Application Set (2 pcs of Filler and Pusher) Percutaneous Posterior Kyphoplasty, Cavity Creation Expander, Metal-Plastic
fX® Bioabsorbable Pin 3mm x 40mm
fX® PLA Interference Screws Ø 9mm x 30mm
fX® Bioabsorbable Cannulated Screw 4.5x60 mm
fX® 2x19-Hole Plate, Straight t=1 mm (for Ø1,5mm screws)
fX SV Radiopaque Kyphoplasty Bone Cement, PMMA, 40g
fX® 6-Hole Plate Curved Short t=1,3mm (for Ø2mm screws)
fX® PLDLLA+TCP 30 Interference Screws Ø 10mm x 35mm
fX® Bioabsorbable Cannulated Screw 4.5x50 mm
fX® Bioabsorbable Screw 2.8mm x 11mm (EMG)
fX® Bioabsorbable Screw 1.5mm x 4mm (4 pcs)
fX® 50mm X 50mm 10x10 Hole t=0,50mm (for Ø1,5mm screws)
fX® Bioabsorbable Pin 1.7mm x 20mm
fX® Bioabsorbable Non-Cannulated Screw 3.5x36 mm
fX® Bioabsorbable Non-Cannulated Screw 3.5x20 mm
fX® PLDLLA+TCP 30 Screws Ø 2,34mm x 10mm
fX® Bioabsorbable Pin 6mm x 40mm
fX® Bioabsorbable Cannulated Screw 4.5x70 mm
fX® Bioabsorbable Cannulated Screw 3.5x36 mm
fX® Bioabsorbable Pin 3.2mm x 50mm
fX® 10-Hole Plate t=1,6mm (for Ø2,5mm screws)
fX® Bioabsorbable Pin 5mm x 50mm
fX® 8-Hole Plate t=1,6mm (for Ø2,5mm screws)
fX® Bioabsorbable Screw 2.5mm x 15mm (EMG)
fX® PLDLLA+TCP 30 Interference Screws Ø 11mm x 25mm
fX® Bioabsorbable Pin 6mm x 60mm
fX® Bioabsorbable Compression Fusion Screw Ø12 x 16 mm
fX® T Plate t=0,50mm (for Ø1,5mm screws)
fX® Bioabsorbable Non-Cannulated Screw 4.5x90 mm
fX® L Plate, Left Short t=1,3mm (for Ø2mm screws)
fX® 4-Hole Plate t=1,6mm (for Ø2,5mm screws)
fX® Bioabsorbable Non-Cannulated Screw 3.2x20 mm
fX® 4-Hole Plate Straight t=1,3mm (for Ø2mm screws)
fX® Bioabsorbable Screw 2mm x 4mm (2 pcs)
fX® PLDLLA+TCP 30 Interference Screws Ø 6mm x 23mm
fX® Bioabsorbable Cannulated Screw 3.2x20 mm
fX® Bioabsorbable Screw 2mm x 8mm (2 pcs)
fX® PLDLLA+TCP 30 Interference Screws Ø 10mm x 25mm
fX® Bioabsorbable Pin 2.0mm x 25mm
fX® Bioabsorbable Pin 3.2mm x 60mm
fX® Bioabsorbable Non-Cannulated Screw 3.2x24 mm
fX® Bioabsorbable Screw 2mm x 9mm (Emg.) (2 pcs)
fX® Bioabsorbable Screw 2mm x 15mm (2 pcs)
fX® X Plate, Short t=0,50mm (for Ø1,5mm screws)
fX® Bioabsorbable Screw 1.5mm x 4mm (10 pcs)
fX® Bioabsorbable Non-Cannulated Screw 4.5x70 mm
fX® Y Plate t=1,3mm (for Ø2mm screws)
fX® PLDLLA+TCP 30 Interference Screws Ø 11mm x 35mm
fX® Bioabsorbable Cannulated Screw 3.5x32 mm
fX® 6-Hole Plate, Straight, Short t=0,50mm (for Ø1,5mm screws)
Model / Reference
SCRW-FXPT30IS725, fXBCAS0108, PN-FXBP340, SCRW-FXPIS930, SCRW-FXBCS4560, C-PLT-FX219HPS115, fXKC-SV, C-PLT-FX6HPCS132, SCRW-FXPT30IS1035, SCRW-FXBCS4550, C-SCRW-FXBSE2811, C-SCRW-FXBS1544, C-PLT-FX505010100515, PN-FXBP1720, SCRW-FXBNCS3536, SCRW-FXBNCS3520, SCRW-FXPT30IS23410, PN-FXBP640, SCRW-FXBCS4570, SCRW-FXBCS3536, PN-FXBP3250, C-PLT-FX10HP1625, PN-FXBP550, C-PLT-FX8HP1625, C-SCRW-FXBSE2515, SCRW-FXPT30IS1125, PN-FXBP660, FN-FXBCFS1216, C-PLT-FXTP0515, SCRW-FXBNCS4590, C-PLT-FXLPLS132, C-PLT-FX4HP1625, SCRW-FXBNCS3220, C-PLT-FX4HPS132, C-SCRW-FXBS242, SCRW-FXPT30IS623, SCRW-FXBCS3220, C-SCRW-FXBS282, SCRW-FXPT30IS1025, PN-FXBP2025, PN-FXBP3260, SCRW-FXBNCS3224, C-SCRW-FXBSE292, C-SCRW-FXBS2152, C-PLT-FXXPE0515, C-SCRW-FXBS15410, SCRW-FXBNCS4570, C-PLT-FXYP132, SCRW-FXPT30IS1135, SCRW-FXBCS3532, C-PLT-FX6HPSE0515
Primary DI / UDI-DI
08681781339590, 08681781335523, 08681781349155, 08681781339842, 08681781349612, 08681781363847, 08681781333710, 08681781363984, 08681781339712, 08681781349605, 08681781363656, 08681781363274, 08681781363861, 08681781348981, 08681781349407, 08681781349360, 08681781339507, 08681781349223, 08681781349629, 08681781349575, 08681781349179, 08681781364103, 08681781349209, 08681781364097, 08681781363632, 08681781339729, 08681781349247, 08681781349254, 08681781363731, 08681781349476, 08681781363922, 08681781364059, 08681781349339, 08681781363991, 08681781363359, 08681781339545, 08681781349506, 08681781363434, 08681781339699, 08681781349001, 08681781349162, 08681781349353, 08681781363458, 08681781363533, 08681781363762, 08681781363281, 08681781349452, 08681781363953, 08681781339743, 08681781349568, 08681781363809
Basic UDI-DI
B-08681781339590, B-08681781335523, B-08681781349155, B-08681781339842, B-08681781349612, B-08681781363847, B-08681781333710, B-08681781363984, B-08681781339712, B-08681781349605, B-08681781363656, B-08681781363274, B-08681781363861, B-08681781348981, B-08681781349407, B-08681781349360, B-08681781339507, B-08681781349223, B-08681781349629, B-08681781349575, B-08681781349179, B-08681781364103, B-08681781349209, B-08681781364097, B-08681781363632, B-08681781339729, B-08681781349247, B-08681781349254, B-08681781363731, B-08681781349476, B-08681781363922, B-08681781364059, B-08681781349339, B-08681781363991, B-08681781363359, B-08681781339545, B-08681781349506, B-08681781363434, B-08681781339699, B-08681781349001, B-08681781349162, B-08681781349353, B-08681781363458, B-08681781363533, B-08681781363762, B-08681781363281, B-08681781349452, B-08681781363953, B-08681781339743, B-08681781349568, B-08681781363809
EMDN Code
P09120605, P099002, P09120606, P900403
Device Class
Class III
Class IIa
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015715

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

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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