510(k) K221087 ยท HAW Neurological Stereotaxic Instrument
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jun 10, 2022 |
| Received | Apr 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Open, Classified |
HAW | None listed |
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.