The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Navlock Trackers.
| Device ID | K201327 |
| 510k Number | K201327 |
| Device Name: | NavLock Trackers |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CA 80027 |
| Contact | Taylor Gold West |
| Correspondent | Taylor Gold West Medtronic Navigation 826 Coal Creek Circle Louisville, CA 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-19 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000381165 | K201327 | 000 |
| 00763000381158 | K201327 | 000 |