510(k) K203115 ยท OLO Orthopedic Stereotaxic Instrument
ARVIS Surgical Navigation System
| Applicant | Insight Medical Systems, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Jul 14, 2021 |
| Received | Oct 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2026 | Kico Knee Innovation Company Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-2 Open, Classified |
OLO | None listed |
| Jun 2, 2026 | Kico Knee Innovation Company Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.