Ceramisys Ltd

Sheffield York, GB

CERAMISYS LTD appears in FDA device records in Sheffield York, GB. FDA records list 2 510(k) clearances between 2011-11-02 and 2011-11-03, 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 Ceramisys Ltd in 2011.

Clearances by year, as a table

510(k) clearance decisions for Ceramisys Ltd, by decision year
Year	Clearances
2011	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K103820	REPROBONE DENTAL GRAFTING MATERIAL	LYC	Substantially Equivalent	2011-11-03
K110554	BIOCERAMIC ORBITAL IMPLANT, ORBTEX	HPZ	Substantially Equivalent	2011-11-02

Registered establishments

FDA registered establishments for Ceramisys Ltd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007708799	3007708799	CERAMISYS LTD	914 Herries Road, Sheffield York S6 1QW GB	2026	HNP HPZ LYC

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