Cleared Traditional

CastleLoc Pectus Bar System

K243357 · L & K Biomed Co., Ltd. · Orthopedic
Feb 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K243357 is an FDA 510(k) clearance for the CastleLoc Pectus Bar System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on February 27, 2025, 121 days after receiving the submission on October 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243357 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date February 27, 2025
Days to Decision 121 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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