K083342 is an FDA 510(k) clearance for the ORBITAL RECONSTRUCTIVE IMPLANT II. This device is classified as a Implant, Eye Sphere (Class II - Special Controls, product code HPZ).
Submitted by Evera Medical, Inc. (Foster City, US). The FDA issued a Cleared decision on March 12, 2009, 120 days after receiving the submission on November 12, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K083342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2008 |
| Decision Date | March 12, 2009 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |