Fine Osteotomy— 510(k) K240066

Name: FDA 510(k) clearance K240066
Creator: U.S. Food and Drug Administration
Published: 2024-02-09

Substantially Equivalent

Bodycad Laboratories, Inc.

FDA 510(k) clearance K240066 for Fine Osteotomy, Substantially Equivalent on 2024-02-09. Applicant: Bodycad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bodycad Laboratories, Inc.
Product code: Code PBF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-01-09
Decision date: 2024-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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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.