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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 4 of 16

Device	Model / Reference	Registries	Class	Status
Apex Femoral Nail GT Right Ø 12.0 x 240mm	F04-120240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 12.0 x 240mm	F05-120240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 480mm	F05-130480	EUDAMED	Class IIb	Active
Apex Femoral Nail GT Left Ø 12.0 x 380mm	F03-120380	EUDAMEDFDA UDI	Class IIb	Active
Modular Reamer Head, Size 16.0	INS-1094	EUDAMEDFDA UDI	Class IIa	Active
K-Wire Trocar (Length 227mm)	INS-1155	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 13.0 x 280mm	F05-130280	EUDAMEDFDA UDI	Class IIb	Active
Flexible IM Reamer Shaft Extension 150mm	INS-1135	EUDAMEDFDA UDI	Class IIa	Active
Apex Tibial Nail Ø 13 x 420mm	T02-130420	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11.5 x 255mm	T02-115255	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 315mm	T02-100315	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 375mm	T02-100375	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 120mm	LB02-50120	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 12.0 x 360mm	F04-120360	EUDAMEDFDA UDI	Class IIb	Active
Modular Reamer Head, Size 9.5	INS-1081	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Left Ø 11.0 x 320mm	F01-110320	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11 x 300mm	T02-110300	EUDAMEDFDA UDI	Class IIb	Active
Apex Endcap Tibial/Retrograde 10mm Length	E04-010	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.0 x 460mm	F01-110460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.5 x 300mm	F04-115300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 240mm	F03-850240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 14.5 x 260mm	F03-145260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 260mm	F03-850260	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11 x 345mm	T02-110345	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 22.5mm	LS02-50022	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 360mm	F04-110360	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 13 x 285mm	T02-130285	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 105mm	LS02-60105	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 8.5 x 420mm	F01-850420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.0 x 300mm	F02-110300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 14.5 x 460mm	F03-145460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.0 x 360mm	F05-110360	EUDAMEDFDA UDI	Class IIb	Active
Suprapatellar Trocar	INS-1122	EUDAMEDFDA UDI	Class I	Active
Suprapatellar Anchoring Protection Sleeve	INS-1119	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Left Ø 8.5 x 300mm	F03-850300	EUDAMEDFDA UDI	Class IIb	Active
Keyless Chuck	INS-1022	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Right Ø 8.5 x 440mm	F02-850440	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 12 x 420mm	T02-120420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 11.0 x 280mm	F04-110280	EUDAMEDFDA UDI	Class IIb	Active
Connecting Bolt (Ø10mm)	INS-1044	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Right Ø 14.5 x 420mm	F02-145420	EUDAMEDFDA UDI	Class IIb	Active
Monobloc Reamer, Size 8.0	INS‐1100	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail GT Left Ø 8.5 x 480mm	F03-850480	EUDAMEDFDA UDI	Class IIb	Active
Purple Ø5.0mm Stepped Twist Drill X Length 370mm (Use Ø5.0mm Locking Bolt)	INS-1054	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Left Ø 10.0 x 320mm	F01-100320	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 420mm	F05-100420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 14.5 x 300mm	F02-145300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 460mm	F05-130460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 440mm	F02-120440	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 40mm	LB02-50040	EUDAMEDFDA UDI	Class IIb	Active

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