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

Other 510(k) Records For Product Code HRS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies2026-09-18
K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.2026-09-15
K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical2026-09-03
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi2026-08-28
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-08-19
K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.2026-08-13
K261511Xpert AnkleNewclip Technics2026-07-28
K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-07-21
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16
K261191Alians Elbow SNewclip Technics2026-07-08
K261054RibPlate SystemStryker Leibinger GmbH & Co KG2026-07-01
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbH2026-06-16
K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026-06-12
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05