The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Navlock Trackers, Robotic Reference Frame.
| Device ID | K182104 |
| 510k Number | K182104 |
| Device Name: | NavLock Trackers, Robotic Reference Frame |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Jainam Shah |
| Correspondent | Jainam Shah 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 | 2018-08-03 |
| Decision Date | 2018-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000231835 | K182104 | 000 |
| 00763000231521 | K182104 | 000 |
| 00763000156626 | K182104 | 000 |
| 00763000123185 | K182104 | 000 |
| 00763000123178 | K182104 | 000 |
| 00763000423094 | K182104 | 000 |