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OrthoXel DAC

Ireland·IE-MF-000000574

Last updated September 18, 2026

About

OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices.

From the manufacturer's own website. Source

Information

Country: Ireland
Address: Cube House, Cork Business and Technology Park, Model Farm Road, Cork, Ireland
Website: www.orthoxel.com/
LinkedIn: linkedin.com/company/orthoxel
Facebook: —
Email: [email protected]
Phone: +353(0)212429700
PRRC Contact: Mark Moynihan
EUDAMED SRN: IE-MF-000000574
FDA FEI Number: —
DUNS Number: —

Catalogue (758)

Page 1 of 16

Device	Model / Reference	Registries	Class	Status
Apex Femoral Nail PF Left Ø 10.0 x 400mm	F01-100400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.0 x 380mm	F05-110380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 10.0 x 380mm	F03-100380	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 105mm	LB02-50105	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 95mm	LB02-60095	EUDAMEDFDA UDI	Class IIb	Active
Multi-Lumen K-Wire Guide	INS-1037	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 12.0 x 360mm	F05-120360	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 13 x 345mm	T02-130345	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.0 x 360mm	F02-110360	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 110mm	LS02-60110	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 285mm	T02-100285	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 10.0 x 280mm	F02-100280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 14.5 x 280mm	F01-145280	EUDAMEDFDA UDI	Class IIb	Active
Flexible IM reamer Shaft 470mm	INS-1095	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail GT Left Ø 8.5 x 400mm	F03-850400	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 420mm	T02-900420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 340mm	F05-100340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 480mm	F02-120480	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 8.5 x 420mm	F05-850420	EUDAMEDFDA UDI	Class IIb	Active
Apex Nailing System Opening and Reaming Kit	INS-1132	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 11.0 x 440mm	F04-110440	EUDAMEDFDA UDI	Class IIb	Active
K-Wire Sleeve	INS-1137	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 10.0 x 300mm	F04-100300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 360mm	F04-130360	EUDAMEDFDA UDI	Class IIb	Active
Endcap Driver	INS-1007	EUDAMED	Class I	Active
Apex Femoral Nail GT Left Ø 8.5 x 380mm	F03-850380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 14.5 x 380mm	F02-145380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 320mm	F05-100320	EUDAMEDFDA UDI	Class IIb	Active
K-Wire Ø3.2mm X Length 350mm	INS-1036	EUDAMEDFDA UDI	Class I	Active
Apex Tibial Nailing System Kit	INS-1134	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Left Ø 10.0 x 300mm	F03-100300	EUDAMEDFDA UDI	Class IIb	Active
Green Outer Drill Sleeve (Length 129mm)	INS-1125	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Right Ø 8.5 x 400mm	F02-850400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.0 x 480mm	F02-110480	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 400mm	F04-110400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 13.0 x 480mm	F03-130480	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 70mm	LB02-50070	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 14.5 x 380mm	F03-145380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 8.5 x 460mm	F04-850460	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 45mm	LB02-50045	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.0 x 340mm	F05-110340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 14.5 x 240mm	F01-145240	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 345mm	T02-100345	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.5 x 480mm	F01-115480	EUDAMEDFDA UDI	Class IIb	Active
Yellow Ø4.25mm Drill X Length 165mm (Use Ø5.0mm Locking Screw)	INS-1056	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Left Ø 12.0 x 320mm	F01-120320	EUDAMEDFDA UDI	Class IIb	Active
Modular Reamer Head, Size 10.5	INS-1083	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Right Ø 11.0 x 280mm	F02-110280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 240mm	F01-120240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 13.0 x 380mm	F01-130380	EUDAMEDFDA UDI	Class IIb	Active

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