K170312 is an FDA 510(k) clearance for the IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on May 15, 2017, 103 days after receiving the submission on February 1, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K170312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2017 |
| Decision Date | May 15, 2017 |
| Days to Decision | 103 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 |