K240212
- 510(k) number
- K240212
- Device name
- COGNiTiON Staple System
- Applicant
- Ortho Solutions UK , Ltd. GB
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2024-02-23
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240212.pdf
Official FDA record: K240212
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.