Orthoxel

Cork Cork, IE

ORTHOXEL appears in FDA device records in Cork Cork, IE. FDA records list 2 510(k) clearances between 2017-12-20 and 2018-07-17, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Orthoxel between 2017 and 2018. The busiest year on record is 2017, with 1. The most recent is 2018, with 1.

Clearances by year, as a table

510(k) clearance decisions for Orthoxel, by decision year
Year	Clearances
2017	1
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K181375	Apex Femoral Nailing System	HSB	Substantially Equivalent	2018-07-17
K170972	Apex Tibial Nailing System	HSB	Substantially Equivalent	2017-12-20

Registered establishments

FDA registered establishments for Orthoxel, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014976005	3014976005	ORTHOXEL	Cube House, Cork Business and Technology Park, Model Farm Road, Cork Cork(City) T12 H966 IE	2026	HSB HTJ HTO HTW HWC HWJ HXC HXI HXX JDS and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain