The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Stealth-midas System.
| Device ID | K160713 |
| 510k Number | K160713 |
| Device Name: | Stealth-Midas System |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169595194 | K160713 | 000 |
| 00763000430986 | K160713 | 000 |
| 00763000430993 | K160713 | 000 |
| 00763000337537 | K160713 | 000 |
| 00763000337544 | K160713 | 000 |
| 00763000080082 | K160713 | 000 |
| 00763000086978 | K160713 | 000 |
| 00763000096779 | K160713 | 000 |
| 00763000172824 | K160713 | 000 |
| 00763000172831 | K160713 | 000 |
| 00763000172848 | K160713 | 000 |
| 00763000172855 | K160713 | 000 |
| 00643169595163 | K160713 | 000 |
| 00643169595170 | K160713 | 000 |
| 00643169595187 | K160713 | 000 |
| 00763000430900 | K160713 | 000 |