Submission Details
| 510(k) Number | K183515 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2018 |
| Decision Date | May 12, 2019 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
MR8 Drill System, Midas Rex MR8 ClearView Tools
May 2019
Decision
145d
Days
Class 2
Risk
About This 510(k) Submission
K183515 is an FDA 510(k) clearance for the MR8 Drill System, Midas Rex MR8 ClearView 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 12, 2019, 145 days after receiving the submission on December 18, 2018. 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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