Clearance Summary
COGNiTiON Staple System received FDA 510(k) clearance under submission number K240212, sponsored by Ortho Solutions UK , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-02-23.
- Submission: K240212
- Applicant / Sponsor: Ortho Solutions UK , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2024-02-23
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.