EmbedMed— 510(k) K221943

Substantially Equivalent

3D Lifeprints UK , Ltd.

FDA 510(k) clearance K221943 for EmbedMed, Substantially Equivalent on 2023-02-01. Applicant: 3D Lifeprints UK , Ltd..

Clearance details

Applicant: 3D Lifeprints UK , Ltd.
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2022-07-05
Decision date: 2023-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Derby, Liverpool, Merseyside, GB

Download summary PDF View on FDA.gov ↗

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.