510(k) K150216 ยท HAW Neurological Stereotaxic Instrument
Synergy Cranial
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jun 11, 2015 |
| Received | Jan 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Open, Classified |
HAW | None listed |
| Nov 11, 2021 | Medtronic Navigation, Inc. Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software.
Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585 Open, Classified |
HAW | None listed |
| Dec 29, 2018 | Medtronic Navigation, Inc. StealthStation Cranial and Synergy Cranial Depth Gauge:
StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.