COGNiTiON Staple System— 510(k) K240212

Substantially Equivalent

Ortho Solutions UK , Ltd.

FDA 510(k) clearance K240212 for COGNiTiON Staple System, Substantially Equivalent on 2024-02-23. Applicant: Ortho Solutions UK , Ltd..

Clearance details

Applicant: Ortho Solutions UK , Ltd.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2024-01-25
Decision date: 2024-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Maldon, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.