Blue Belt Technologies, Inc.
Blue Belt Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Blue Belt Technologies, Inc.
FDA recalls by Blue Belt Technologies, Inc.
- Z-2135-2024 — CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold
- 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Blue Belt Technologies, Inc.
- K260601 — REAL INTELLIGENCE CORI
- K252841 — REAL INTELLIGENCE CORI XT (CORI XT)
- K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K240139 — Real Intelligence CORI
- K231963 — REAL INTELLIGENCE CORI
- K221224 — REAL INTELLIGENCE CORI
- K220958 — Real Intelligence Cori
- K220255 — REAL INTELLIGENCE CORI
- K212040 — RI.HIP MODELER
- K212537 — REAL INTELLIGENCE CORI (CORI)
- K201022 — REAL INTELLIGENCE CORI (CORI)
- K193120 — Real Intelligence Cori
- K191223 — NAVIO
- K180271 — NAVIO Surgical System (NAVIO system)
- K170360 — NAVIO
- K160537 — Navio
- K152574 — Navio
- K143668 — Navio
- K140596 — NAVIO
- K123380 — STRIDE UNICONDYLAR KNEE
- K121936 — NAVIOPFS
Data sourced from openFDA. This site is unofficial and independent of the FDA.