FDA.reportPublic FDA data

510(k) K243357

Device
CastleLoc Pectus Bar System
Applicant
L&K BIOMED Co., Ltd.
510(k) number
K243357
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-10-29
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

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#

510(k) summary PDF

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