K260448
- 510(k) number
- K260448
- Device name
- CastleLoc Pectus Bar System
- Applicant
- L&K BIOMED Co., Ltd. KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-03-19
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260448.pdf
Official FDA record: K260448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.