The following data is part of a premarket notification filed by Ceramisys Ltd. with the FDA for Bioceramic Orbital Implant, Orbtex.
| Device ID | K110554 |
| 510k Number | K110554 |
| Device Name: | BIOCERAMIC ORBITAL IMPLANT, ORBTEX |
| Classification | Implant, Eye Sphere |
| Applicant | CERAMISYS LTD. 344 ANNABELLE POINT ROAD Centercille, MA 02632 -2402 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch CERAMISYS LTD. 344 ANNABELLE POINT ROAD Centercille, MA 02632 -2402 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060171621997 | K110554 | 000 |
| 05060171621874 | K110554 | 000 |
| 05060171621881 | K110554 | 000 |
| 05060171621898 | K110554 | 000 |
| 05060171621904 | K110554 | 000 |
| 05060171621911 | K110554 | 000 |
| 05060171621928 | K110554 | 000 |
| 05060171621935 | K110554 | 000 |
| 05060171621942 | K110554 | 000 |
| 05060171621959 | K110554 | 000 |
| 05060171621966 | K110554 | 000 |
| 05060171621973 | K110554 | 000 |
| 05060171621980 | K110554 | 000 |
| 05060171621867 | K110554 | 000 |