REAL INTELLIGENCE CORI— 510(k) K231963
Substantially EquivalentBlue Belt Technologies, Inc.
FDA 510(k) clearance K231963 for REAL INTELLIGENCE CORI, Substantially Equivalent on 2023-08-01. Applicant: Blue Belt Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Blue Belt Technologies, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pittsburgh, PA, US
Recent devices under product code OLO
view allMore clearances from Blue Belt Technologies, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K231963
K-number listed on FDA's recall record- Z-0708-2024 — CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
- Z-0041-2024 — Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231963.
Data sourced from openFDA. This site is unofficial and independent of the FDA.