FDA.report

510(k) K260448

Device
CastleLoc Pectus Bar System
Applicant
L&K BIOMED Co., Ltd.
510(k) number
K260448
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-19
Date received
2026-02-11
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kihyang Kim
Address
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung-Gu, Yongin-Si KR 17015 17015

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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