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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 2 of 16

Device	Model / Reference	Registries	Class	Status
Locking Bolt Ø6 x 85mm	LB02-60085	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.0 x 380mm	F02-110380	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 12 x 285mm	T02-120285	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 8.5 x 280mm	F01-850280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 13.0 x 280mm	F02-130280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 380mm	F04-110380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 10.0 x 360mm	F01-100360	EUDAMEDFDA UDI	Class IIb	Active
Modular Reamer Head, Size 11.5	INS-1085	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail Retrograde Ø 12.0 x 480mm	F05-120480	EUDAMED	Class IIb	Active
Locking Screw Driver	INS-1008	EUDAMED	Class I	Active
Apex Femoral Nail PF Left Ø 12.0 x 340mm	F01-120340	EUDAMEDFDA UDI	Class IIb	Active
Large AO to ZIH Adapter	INS-1191	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail GT Right Ø 11.5 x 340mm	F04-115340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 8.5 x 240mm	F04-850240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 8.5 x 300mm	F04-850300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 480mm	F01-120480	EUDAMEDFDA UDI	Class IIb	Active
Monobloc Reamer, Size 6.0	INS‐1096	EUDAMEDFDA UDI	Class IIa	Active
Locking Bolt Ø5 x 65mm	LB02-50065	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 12.0 x 420mm	F05-120420	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 75mm	LB02-50075	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 460mm	F03-850460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 420mm	F04-115420	EUDAMEDFDA UDI	Class IIb	Active
Green Outer Drill Sleeve	INS-1046	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Left Ø 14.5 x 340mm	F01-145340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 260mm	F05-100260	EUDAMEDFDA UDI	Class IIb	Active
"Orange Ø4.9mm Twist Drill X Length 370mm (Use Ø6.0mm Locking Screw)"	INS-1053	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail GT Right Ø 12.0 x 380mm	F04-120380	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 300mm	F05-100300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 8.5 x 360mm	F05-850360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.5 x 420mm	F03-115420	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 8.5 x 405mm	T02-850405	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 405mm	T02-100405	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.5 x 260mm	F01-115260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 13.0 x 360mm	F03-130360	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 40mm	LS02-60040	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 330mm	T02-100330	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 300mm	T02-100300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.0 x 420mm	F01-110420	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 270mm	T02-900270	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 480mm	F04-115480	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 10.0 x 240mm	F03-100240	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 375mm	T02-900375	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 8.5 x 420mm	F02-850420	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 115mm	LS02-50115	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 280mm	F04-130280	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 400mm	F05-100400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 260mm	F04-115260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.0 x 260mm	F03-110260	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 13 x 360mm	T02-130360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 240mm	F04-115240	EUDAMEDFDA UDI	Class IIb	Active

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