Locking Plates and Screws Systems— 510(k) K240958

Name: FDA 510(k) clearance K240958
Creator: U.S. Food and Drug Administration
Published: 2025-02-10

Substantially Equivalent

Hebei Ruihe Medical Devices Co., Ltd.

FDA 510(k) clearance K240958 for Locking Plates and Screws Systems, Substantially Equivalent on 2025-02-10. Applicant: Hebei Ruihe Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hebei Ruihe Medical Devices Co., Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-04-08
Decision date: 2025-02-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shijiazhuang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
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

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.