The following data is part of a premarket notification filed by Navinetics, Inc with the FDA for Navinetics D1 Stereotactic System.
| Device ID | K210700 |
| 510k Number | K210700 |
| Device Name: | NaviNetics D1 Stereotactic System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | NaviNetics, Inc 206 S Broadway, Suite 700 Rochester, MN 55904 |
| Contact | Patrick Gora |
| Correspondent | Patrick Gora NaviNetics, Inc 206 S Broadway, Suite 700 Rochester, MN 55904 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-09 |
| Decision Date | 2021-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850023620160 | K210700 | 000 |
| 10850023620016 | K210700 | 000 |
| 10850023620023 | K210700 | 000 |
| 10850023620030 | K210700 | 000 |
| 10850023620047 | K210700 | 000 |
| 10850023620054 | K210700 | 000 |
| 10850023620078 | K210700 | 000 |
| 10850023620061 | K210700 | 000 |
| 10850023620153 | K210700 | 000 |
| 10850023620009 | K210700 | 000 |