Is this your brand? Sign in to claim ownership.

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 3 of 16

Device	Model / Reference	Registries	Class	Status
Apex Femoral Nail Retrograde Ø 12.0 x 460mm	F05-120460	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 10.0 x 360mm	F05-100360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 300mm	F05-130300	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 12.0 x 480mm	F03-120480	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 10.0 x 480mm	F02-100480	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø5 x 25mm	LS02-50025	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 12.0 x 340mm	F05-120340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 240mm	F05-130240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 10.0 x 260mm	F01-100260	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 10.0 x 320mm	F04-100320	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.0 x 320mm	F03-110320	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 10.0 x 440mm	F02-100440	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 8.5 x 380mm	F02-850380	EUDAMEDFDA UDI	Class IIb	Active
Blue Ø6.0mm Stepped Twist Drill X Length 370mm (Use Ø6.0mm Locking Bolt)	INS-1055	EUDAMEDFDA UDI	Class IIa	Active
Apex Tibial Nail Ø 9.0 x 360mm	T02-900360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 11.0 x 380mm	F03-110380	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 390mm	T02-900390	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 52.5mm	LB02-50052	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 13 x 405mm	T02-130405	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 14.5 x 240mm	F04-145240	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 12 x 315mm	T02-120315	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 10.0 x 460mm	F03-100460	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 9.0 x 315mm	T02-900315	EUDAMEDFDA UDI	Class IIb	Active
Locking Bolt Ø5 x 85mm	LB02-50085	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 12.0 x 260mm	F04-120260	EUDAMEDFDA UDI	Class IIb	Active
Suprapatellar Protection Sleeve Handle Connector	INS‐1118	EUDAMEDFDA UDI	Class IIa	Active
Apex Femoral Nail PF Right Ø 13.0 x 400mm	F02-130400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Left Ø 8.5 x 280mm	F03-850280	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 8.5 x 270mm	T02-850270	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.0 x 240mm	F01-110240	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 8.5 x 400mm	F01-850400	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 12.0 x 240mm	F02-120240	EUDAMEDFDA UDI	Class IIb	Active
Suprapatellar K-Wire Guide	INS-1121	EUDAMEDFDA UDI	Class I	Active
Modular Reamer Head, Size 11.0	INS-1084	EUDAMEDFDA UDI	Class IIa	Active
Apex Tibial Nail Ø 11.5 x 315mm	T02-115315	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 10 x 270mm	T02-100270	EUDAMEDFDA UDI	Class IIb	Active
Locking Screw Ø6 x 55mm	LS02-60055	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.5 x 440mm	F01-115440	EUDAMEDFDA UDI	Class IIb	Active
Vertex Hip Fracture Nailing System	K233910	FDA 510(k)	Class II	Active
Apex Femoral Nail GT Left Ø 11.0 x 340mm	F03-110340	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail GT Right Ø 12.0 x 480mm	F04-120480	EUDAMEDFDA UDI	Class IIb	Active
Supine Driver	INS-1012	EUDAMED	Class I	Active
Locking Bolt Ø5 x 72.5mm	LB02-50072	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 13.0 x 320mm	F02-130320	EUDAMEDFDA UDI	Class IIb	Active
Apex Antegrade Femoral Endcap 20mm length	E02-020	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 13.0 x 440mm	F05-130440	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Left Ø 11.5 x 360mm	F01-115360	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail Retrograde Ø 11.5 x 420mm	F05-115420	EUDAMEDFDA UDI	Class IIb	Active
Apex Tibial Nail Ø 11 x 390mm	T02-110390	EUDAMEDFDA UDI	Class IIb	Active
Apex Femoral Nail PF Right Ø 10.0 x 240mm	F02-100240	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.