K250892
- 510(k) number
- K250892
- Device name
- CastleLoc Pectus Bar System
- Applicant
- L&K BIOMED Co., Ltd. KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-04-25
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K250892.pdf
Official FDA record: K250892
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.