Submission Details
| 510(k) Number | K170312 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
May 2017
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 882.4360.
Device Classification
| Product Code | HBC — Motor, Drill, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4360 |
Manufacturer
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