Data / Medical devices / United States / Navinetics Inc.
Navinetics Inc.: FDA-registered device maker in Rochester, MN, United States, 2 510(k) clearances
Navinetics Inc. is registered with the FDA (registration 3023194190) in Rochester, MN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023194190
- Address
- 206 South Broadway Suite 700, Rochester, MN, United States, 55904
- Owner or operator
- NaviNetics Inc. (10085549)
- Roles
- Specification developer
- First device listed
- June 30, 2022
- Registered through
- 2026
- Brand names listed
- NaviNetics Reusable (D1) Stereotactic System, NaviNetics Reusable Stereotactic System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2023 | K231392 | NaviNetics Reusable Stereotactic System (NN1000) | HAW | Substantially Equivalent | Navinetics, Inc. | accessdata.fda.gov |
| June 17, 2021 | K210700 | NaviNetics D1 Stereotactic System | HAW | Substantially Equivalent | Navinetics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 26, 2024 | 94163 | Class II | Ongoing | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Ke | accessdata.fda.gov |
Compare with other makers
Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.