The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions (mpss) with the FDA for Midas Rex Attachments And Dissecting Tools.
| Device ID | K202552 |
| 510k Number | K202552 |
| Device Name: | Midas Rex Attachments And Dissecting Tools |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Powered Surgical Solutions (MPSS) 4620 North Beach Street Fort Worth, TX 76137 |
| Contact | Jainam Shah |
| Correspondent | Jainam Shah Medtronic Powered Surgical Solutions (MPSS) 4620 North Beach Street Fort Worth, TX 76137 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-03 |
| Decision Date | 2020-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000335816 | K202552 | 000 |
| 00763000335892 | K202552 | 000 |
| 00763000335885 | K202552 | 000 |
| 00763000335878 | K202552 | 000 |
| 00763000335861 | K202552 | 000 |
| 00763000335854 | K202552 | 000 |
| 00763000335847 | K202552 | 000 |
| 00763000335830 | K202552 | 000 |
| 00763000335823 | K202552 | 000 |
| 00763000585273 | K202552 | 000 |
| 00763000335694 | K202552 | 000 |
| 00763000335700 | K202552 | 000 |
| 00763000335717 | K202552 | 000 |
| 00763000335809 | K202552 | 000 |
| 00763000335793 | K202552 | 000 |
| 00763000335786 | K202552 | 000 |
| 00763000335779 | K202552 | 000 |
| 00763000335762 | K202552 | 000 |
| 00763000335755 | K202552 | 000 |
| 00763000335748 | K202552 | 000 |
| 00763000335731 | K202552 | 000 |
| 00763000335724 | K202552 | 000 |
| 00763000585266 | K202552 | 000 |