K173066 is an FDA 510(k) clearance for the OSSEODUO Shaver and Drill System. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on June 22, 2018, 266 days after receiving the submission on September 29, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K173066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | June 22, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC - Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |