CastleLoc Pectus Bar System— 510(k) K243357

Name: FDA 510(k) clearance K243357
Creator: U.S. Food and Drug Administration
Published: 2025-02-27

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K243357 for CastleLoc Pectus Bar System, Substantially Equivalent on 2025-02-27. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-10-29
Decision date: 2025-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

More clearances from L&K BIOMED Co., Ltd.

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K262489 — BluEX Cervical Expandable Cage System2026-08-18
K260840 — BluEX Cervical Expandable Cage System2026-05-16
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K261130 — AccelFix Spinal Fixation System2026-05-05
K260448 — CastleLoc Pectus Bar System2026-03-19

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.