Cleared Special

CastleLoc Pectus Bar System

K250892 · L & K Biomed Co., Ltd. · Orthopedic
Apr 2025
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K250892 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 April 25, 2025, 31 days after receiving the submission on March 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250892 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2025
Decision Date April 25, 2025
Days to Decision 31 days
Submission Type Special
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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