510(k) K231963 · OLO Orthopedic Stereotaxic Instrument
REAL INTELLIGENCE CORI
| Applicant | Blue Belt Technologies, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Aug 1, 2023 |
| Received | Jul 3, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2024 | Blue Belt Technologies, Inc CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Open, Classified |
OLO | None listed |
| Oct 5, 2023 | Blue Belt Technologies, Inc Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5)
Product Number: ROB10299 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.