CORIOGRAPH Pre-Op Planning and Modeling Services— 510(k) K250921

Name: FDA 510(k) clearance K250921
Creator: U.S. Food and Drug Administration
Published: 2025-06-25

Substantially Equivalent

Blue Belt Technologies, Inc.

FDA 510(k) clearance K250921 for CORIOGRAPH Pre-Op Planning and Modeling Services, Substantially Equivalent on 2025-06-25. Applicant: Blue Belt Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Blue Belt Technologies, Inc.
Product code: Code PBF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-03-27
Decision date: 2025-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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K242603 — MyPAO SA guides2025-11-19
K251709 — MedCAD® AccuStride System2025-11-04
K250394 — Fine TTO2025-10-21

More clearances from Blue Belt Technologies, Inc.

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K260601 — REAL INTELLIGENCE CORI2026-03-26
K252841 — REAL INTELLIGENCE CORI XT (CORI XT)2025-12-05
K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services2024-11-15
K240139 — Real Intelligence CORI2024-03-18
K231963 — REAL INTELLIGENCE CORI2023-08-01

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.