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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 12 of 16

Device	Model / Reference	Registries	Class	Status
Modular Reamer Head, Size 12.5	INS-1087	EUDAMEDFDA UDI	Class IIa	Active
Locking Screw Ø5 x 47.5mm	LS02-50047	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 35mm	LS02-50035	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 8.5 x 300mm	F05-850300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 300mm	F02-120300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 280mm	F01-120280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 13.0 x 420mm	F02-130420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 14.5 x 340mm	F03-145340	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 60mm	LS02-60060	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nailing System Case	INS-1131	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 13.0 x 440mm	F04-130440	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 37.5mm	LS02-50037	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.5 x 300mm	F03-115300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 10.0 x 260mm	F03-100260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 320mm	F04-130320	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 65mm	LS02-60065	EUDAMEDFDA UDI	Class IIb	Active
M9 Extraction Adapter	INS-1152	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 11.0 x 280mm	F05-110280	EUDAMEDFDA UDI	Class IIb	Active
Femur Antegrade Recon PF Module	INS-1042	EUDAMEDFDA UDI	Class I	Active
Locking Screw Ø5 x 32.5mm	LS02-50032	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 260mm	F01-120260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 14.5 x 260mm	F02-145260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 400mm	F02-120400	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 420mm	T02-100420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 14.5 x 340mm	F02-145340	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 50mm	LS02-60050	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 13.0 x 420mm	F01-130420	EUDAMEDFDA UDI	Class IIb	Active
Straight AO Mount Handle	INS-1107	EUDAMED	Class I	Active
Apex Femoral Nail GT Right Ø 8.5 x 280mm	F04-850280	EUDAMEDFDA UDI	Class IIb	Active
Apex Endcap Tibial/Retrograde 15mm Length	E04-015	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 75mm	LB02-60075	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 14.5 x 320mm	F01-145320	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 62.5mm	LS02-50062	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 12.0 x 280mm	F04-120280	EUDAMEDFDA UDI	Class IIb	Active
Purple Ø5.0mm Drill Sleeve	INS-1049	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 11.5 x 380mm	F05-115380	EUDAMEDFDA UDI	Class IIb	Active
Blue Ø6.0mm Drill Sleeve	INS-1050	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 11.0 x 260mm	F04-110260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 240mm	F04-130240	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 90mm	LB02-60090	EUDAMEDFDA UDI	Class IIb	Active
Long Insertion Handle	INS-1110	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 13.0 x 380mm	F05-130380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 420mm	F05-130420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 10.0 x 440mm	F04-100440	EUDAMEDFDA UDI	Class IIb	Active
Modular Reamer Head, Size 13.5	INS-1089	EUDAMEDFDA UDI	Class IIa	Active
Apex Tibial Nail Ø 8.5 x 285mm	T02-850285	EUDAMEDFDA UDI	Class IIb	Active
Hex Driver (5mm/8mm)	INS-1075	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 14.5 x 460mm	F04-145460	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 50mm	LB02-60050	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 9.0 x 240mm	F05-900240	EUDAMEDFDA UDI	Class IIb	Active

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