K162544 is an FDA 510(k) clearance for the OsteoMed PINNACLE Driver. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on April 4, 2017, 204 days after receiving the submission on September 12, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K162544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2016 |
| Decision Date | April 04, 2017 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KMW - Handpiece, Rotary Bone Cutting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |