K091636 is an FDA 510(k) clearance for the OSTENE CT, AOC CT, OSTEOTENE, CERETENE. This device is classified as a Wax, Bone.
Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 22, 2009, 18 days after receiving the submission on June 4, 2009.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K091636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2009 |
| Decision Date | June 22, 2009 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |