The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Mr8 Drill System.
| Device ID | K163565 |
| 510k Number | K163565 |
| Device Name: | MR8 Drill System |
| Classification | Motor, Drill, Electric |
| Applicant | MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Contact | Deep Pal |
| Correspondent | John Connor MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Product Code | HBC |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169912137 | K163565 | 000 |