CastleLoc Pectus Bar System— 510(k) K260448
Substantially EquivalentL&K BIOMED Co., Ltd.
FDA 510(k) clearance K260448 for CastleLoc Pectus Bar System, Substantially Equivalent on 2026-03-19. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.
Summary
L&K BIOMED's CastleLoc Pectus Bar System is filed under HRS, bone fixation plates. The record doesn't list bar sizes or components.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It was a Special 510(k).
L&K BIOMED filed from Yongin-Si, South Korea. The decision came 36 calendar days after receipt (February 11 to March 19, 2026).
Clearance details
- Applicant
- L&K BIOMED Co., Ltd.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yongin-Si, KR
Recent devices under product code HRS
view allMore clearances from L&K BIOMED Co., Ltd.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.