The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Ziehm Rfd 3d Tracker.
| Device ID | K180816 |
| 510k Number | K180816 |
| Device Name: | Ziehm RFD 3D Tracker |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Nicole Zimmerman |
| Correspondent | Nicole Zimmerman 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 | 2018-03-29 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000114596 | K180816 | 000 |