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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 14 of 16

Device	Model / Reference	Registries	Class	Status
Apex Tibial Nail Ø 8.5 x 255mm	T02-850255	EUDAMEDFDA UDI	Class IIb	Active
Tube Tissue Protector	INS-1039	EUDAMEDFDA UDI	Class I	Active
Locking Bolt Ø6 x 40mm	LB02-60040	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.5 x 260mm	F05-115260	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 80mm	LB02-50080	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nailing System Kit	INS-1133	EUDAMEDFDA UDI	Class I	Active
Locking Screw Ø6 x 80mm	LS02-60080	EUDAMEDFDA UDI	Class IIb	Active
Apex Antegrade Femoral Locking Endcap 0mm Length	LE02-000	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 13.0 x 380mm	F02-130380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 460mm	F05-100460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 10.0 x 400mm	F03-100400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.0 x 400mm	F05-110400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 8.5 x 460mm	F02-850460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 340mm	F04-110340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 340mm	F03-850340	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 60mm	LB02-50060	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.5 x 400mm	F05-115400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 420mm	F04-130420	EUDAMEDFDA UDI	Class IIb	Active
Tibial Infrapatellar Insertion Handle	INS-1109	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 14.5 x 340mm	F04-145340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 10.0 x 480mm	F01-100480	EUDAMEDFDA UDI	Class IIb	Active
Mallet	INS-1065	EUDAMEDFDA UDI	Class I	Active
Monobloc Reamer, Size 7.0	INS‐1098	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail Retrograde Ø 13.0 x 260mm	F05-130260	EUDAMEDFDA UDI	Class IIb	Active
Driver With Retention Hex (5mm)	INS-1059	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Left Ø 11.5 x 300mm	F01-115300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 480mm	F04-110480	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.5 x 420mm	F01-115420	EUDAMEDFDA UDI	Class IIb	Active
3.5mm Hex Short Driver Shaft	INS-1108	EUDAMED	Class I	Active
Locking Bolt Ø5 x 42.5mm	LB02-50042	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 10.0 x 380mm	F04-100380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 320mm	F02-120320	EUDAMEDFDA UDI	Class IIb	Active
Apex Antegrade Femoral Endcap 15mm length	E02-015	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 45mm	LB02-60045	EUDAMEDFDA UDI	Class IIb	Active
Yellow Trocar (Length 150mm)	INS-1126	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Right Ø 13.0 x 360mm	F02-130360	EUDAMEDFDA UDI	Class IIb	Active
Modular Straight Handle	INS-1071	EUDAMEDFDA UDI	Class I	Active
M12 Adapter Bolt	INS-1130	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 9.0 x 320mm	F05-900320	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 10.0 x 460mm	F01-100460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 13.0 x 280mm	F03-130280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 280mm	F04-115280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.0 x 260mm	F02-110260	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 62.5mm	LB02-50062	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 60mm	LB02-60060	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11 x 255mm	T02-110255	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 12.0 x 340mm	F03-120340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 9.0 x 440mm	F05-900440	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 10.0 x 380mm	F01-100380	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 345mm	T02-900345	EUDAMEDFDA UDI	Class IIb	Active

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