SIGNEX— 510(k) K243469

Name: FDA 510(k) clearance K243469
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K243469 for SIGNEX, Substantially Equivalent on 2025-05-29. Applicant: Osteonic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-11-08
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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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 Osteonic Co., Ltd.

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K254182 — Aster2026-02-26
K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2024-12-03
K243470 — Fix2Lock (PEEK Self Punching)2024-12-03
K230546 — SIGNEX2024-06-11
K233659 — Suture Wing2023-12-26

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.