K110554 is an FDA 510(k) clearance for the BIOCERAMIC ORBITAL IMPLANT, ORBTEX. This device is classified as a Implant, Eye Sphere (Class II - Special Controls, product code HPZ).
Submitted by Ceramisys, Ltd. (Centercille, US). The FDA issued a Cleared decision on November 2, 2011, 247 days after receiving the submission on February 28, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K110554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2011 |
| Decision Date | November 02, 2011 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |