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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 6 of 16

Device	Model / Reference	Registries	Class	Status
Apex Femoral Nail Retrograde Ø 11.5 x 460mm	F05-115460	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 8.5 x 345mm	T02-850345	EUDAMEDFDA UDI	Class IIb	Active
Module Connection Bolt	INS-1103	EUDAMEDFDA UDI	Class I	Active
Apex Tibial Nail Ø 10 x 255mm	T02-100255	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 13.0 x 260mm	F04-130260	EUDAMEDFDA UDI	Class IIb	Active
Retrograde Targeting Guide	INS-1139	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 10.0 x 240mm	F05-100240	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 12 x 345mm	T02-120345	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 440mm	F01-120440	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11 x 375mm	T02-110375	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 110mm	LB02-50110	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 9.0 x 340mm	F05-900340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.5 x 460mm	F03-115460	EUDAMEDFDA UDI	Class IIb	Active
Apex Antegrade Femoral Endcap 0mm Length	E02-000	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 340mm	F05-130340	EUDAMEDFDA UDI	Class IIb	Active
Apex Nailing System Retrograde Kit	INS-1150	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail Retrograde Ø 9.0 x 360mm	F05-900360	EUDAMEDFDA UDI	Class IIb	Active
K-Wire Ø3.2mm X Length 250mm	INS-1068	EUDAMEDFDA UDI	Class I	Active
Reamer / Nail Diameter Length Gauge	INS-1011	EUDAMEDFDA UDI	Class I	Active
Opening Reamer Ø13.0mm	INS‐1106	EUDAMEDFDA UDI	Class IIa	Active
Locking Screw Ø5 x 57.5mm	LS02-50057	EUDAMEDFDA UDI	Class IIb	Active
Ø2.5x900mm Guidewire with Ball Tip	INS-1069S	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Left Ø 8.5 x 320mm	F01-850320	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 360mm	T02-100360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 12.0 x 440mm	F04-120440	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 360mm	F02-120360	EUDAMEDFDA UDI	Class IIb	Active
Yellow Ø4.25mm Twist Drill X Length 370mm (Use Ø5.0mm Locking Screw)	INS-1052	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Left Ø 12.0 x 400mm	F01-120400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 12.0 x 300mm	F03-120300	EUDAMEDFDA UDI	Class IIb	Active
Long Screw Driver With Retention Hex (3.5mm) [A&B]	INS-1060	EUDAMEDFDA UDI	Class I	Active
Tibial Targeting Guide	INS-1111	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail GT Right Ø 11.5 x 440mm	F04-115440	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 13.0 x 240mm	F03-130240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 14.5 x 240mm	F02-145240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 9.0 x 480mm	F05-900480	EUDAMED	Class IIb	Active
Locking Bolt Ø6 x 110mm	LB02-60110	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 12.0 x 360mm	F01-120360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 13.0 x 380mm	F03-130380	EUDAMEDFDA UDI	Class IIb	Active
Long Connecting Bolt	INS-1116	EUDAMEDFDA UDI	Class I	Active
Tibial Targeting Guide Locking Bolt	INS-1112	EUDAMEDFDA UDI	Class I	Active
Apex Tibial Nail Ø 11.5 x 375mm	T02-115375	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 100mm	LB02-60100	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø6 x 105mm	LB02-60105	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 8.5 x 340mm	F02-850340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 360mm	F03-850360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 11.5 x 340mm	F02-115340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 9.0 x 420mm	F05-900420	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 12.0 x 400mm	F05-120400	EUDAMEDFDA UDI	Class IIb	Active
Ø12 Cannulated Curved Awl	INS-1105	EUDAMEDFDA UDI	Class I	Active
Apex Femoral Nail PF Right Ø 8.5 x 480mm	F02-850480	EUDAMEDFDA UDI	Class IIb	Active

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