Data / Medical devices / United Kingdom / Ceramisys Ltd
Ceramisys Ltd: FDA-registered device maker in Sheffield York, United Kingdom, 2 510(k) clearances
Ceramisys Ltd is registered with the FDA (registration 3007708799) in Sheffield York, United Kingdom. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 3, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007708799
- Address
- 914 Herries Road, Sheffield York, United Kingdom, S6 1QW
- Owner or operator
- Ceramisys Ltd (10029778)
- Roles
- Manufacturer
- First device listed
- December 26, 2011
- Registered through
- 2026
- Brand names listed
- Ceramisys Bioceramic Alumina Implant, ReproBone¿ Synthetic, Resorbable Bone Graft Substitute, orbital implant inserter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Eye Sphere | HPZ | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Sphere | HNP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2011 | K103820 | REPROBONE DENTAL GRAFTING MATERIAL | LYC | Substantially Equivalent | Ceramisys, Ltd. | accessdata.fda.gov |
| November 2, 2011 | K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | HPZ | Substantially Equivalent | Ceramisys, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Sphere
- All makers of Implant, Eye Sphere
- All makers of Bone Grafting Material, Synthetic
Updated November 3, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.