The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Stealth-midas Mr8 System.
| Device ID | K183644 |
| 510k Number | K183644 |
| Device Name: | Stealth-Midas MR8 System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth, TX 76137 |
| Contact | Jenna Groves |
| Correspondent | Jenna Groves Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 |
| Product Code | OLO |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HBC |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169912205 | K183644 | 000 |
| 00643169912168 | K183644 | 000 |
| 00643169912151 | K183644 | 000 |
| 00763000063979 | K183644 | 000 |
| 00763000063337 | K183644 | 000 |
| 00763000374730 | K183644 | 000 |
| 00763000431020 | K183644 | 000 |
| 00763000430924 | K183644 | 000 |