Clearance Summary
WasherCap Mini Fixation System (Model 45) received FDA 510(k) clearance under submission number K243712, sponsored by Abanza Tecnomed S.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-01-30.
- Submission: K243712
- Applicant / Sponsor: Abanza Tecnomed S.L
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2025-01-30
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.