510(k) K240212
K240212 is an FDA 510(k) premarket notification submitted by Ortho Solutions UK , Ltd. for the device "COGNiTiON Staple System". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ortho Solutions UK , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2024
- Date Received
- January 25, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type