Pittsburgh, PA, US · 13 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 10 | 2026-03-26 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Class II | Orthopedic | 1 | 2025-06-25 |
| — | — | — | — | 1 | 2024-11-15 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2022-03-11 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-05-07 | Class II | Ongoing | Z-2135-2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw… | — | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen o… |
| 2023-11-13 | Class II | Ongoing | Z-0708-2024 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | — | Possibility that the user is unable to resolve drill disconnection error messages. |
| 2023-09-07 | Class II | Ongoing | Z-0041-2024 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102… | — | CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) w… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-26 | K260601 | REAL INTELLIGENCE CORI | OLO | Class II | Neurology |
| 2025-12-05 | K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | OLO | Class II | Neurology |
| 2025-06-25 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | PBF | Class II | Orthopedic |
| 2024-11-15 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | — | — | — |
| 2024-03-18 | K240139 | Real Intelligence CORI | OLO | Class II | Neurology |
| 2023-08-01 | K231963 | REAL INTELLIGENCE CORI | OLO | Class II | Neurology |
| 2022-08-19 | K221224 | REAL INTELLIGENCE CORI | OLO | Class II | Neurology |
| 2022-07-27 | K220958 | Real Intelligence Cori | OLO | Class II | Neurology |
| 2022-03-29 | K220255 | REAL INTELLIGENCE CORI | OLO | Class II | Neurology |
| 2022-03-11 | K212040 | RI.HIP MODELER | LLZ | Class II | Radiology |
| 2021-11-03 | K212537 | REAL INTELLIGENCE CORI (CORI) | OLO | Class II | Neurology |
| 2020-06-12 | K201022 | REAL INTELLIGENCE CORI (CORI) | OLO | Class II | Neurology |
| 2020-02-14 | K193120 | Real Intelligence Cori | OLO | Class II | Neurology |