Blue Ortho
Blue Ortho holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2024, with 3 FDA device recalls on record.
Top product codes for Blue Ortho
FDA recalls by Blue Ortho
- Z-0209-2025 — Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
- Z-0288-2021 — Instructions For Use document of the GPS Trackers.
- Z-1149-2020 — Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
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 Ortho
- K233299 — ExactechGPS® System
- K232521 — ExactechGPS® Total Ankle Application
- K213877 — ExactechGPS® System
- K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K193618 — ExactechGPS System
- K173372 — ExactechGPS Total Shoulder Application
- K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K152764 — EXACTECH GPS
- K100742 — EXACTECH GPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.