Clearance Summary
CastleLoc Pectus Bar System received FDA 510(k) clearance under submission number K250892, sponsored by L&K BIOMED Co., 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 2025-04-25.
- Submission: K250892
- Applicant / Sponsor: L&K BIOMED Co., Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-04-25
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.