Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Blue Ortho with 10 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Oct 26, 2026: GPS Ankle.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 26, 2026 | GPS AnkleK262567 · OLO | 510(k) clearances |
| Aug 30, 2024 | Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes aClass II · Predict+ is being recalled for lack of pre-market clearance/approval. | Device recalls |
| Jan 26, 2024 | ExactechGPS® SystemK233299 · OLO | 510(k) clearances |
| Nov 16, 2023 | ExactechGPS® Total Ankle ApplicationK232521 · OLO | 510(k) clearances |
| May 2, 2022 | ExactechGPS® SystemK213877 · OLO | 510(k) clearances |
| Jan 6, 2022 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareK213546 · OLO | 510(k) clearances |
| Sep 10, 2020 | Instructions For Use document of the GPS Trackers.Class II · Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature steril | Device recalls |
| Sep 2, 2020 | ExactechGPS SystemK193618 · OLO | 510(k) clearances |
| Sep 22, 2019 | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog ReferClass II · The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong d | Device recalls |
| Nov 24, 2017 | ExactechGPS Total Shoulder ApplicationK173372 · OLO | 510(k) clearances |
| Apr 5, 2017 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareK162567 · OLO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
