K060987 is an FDA 510(k) clearance for the OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31. This device is classified as a Wax, Bone.
Submitted by Cp Medical (Buford, US). The FDA issued a Cleared decision on November 2, 2006, 206 days after receiving the submission on April 10, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K060987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2006 |
| Decision Date | November 02, 2006 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |