DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS— 510(k) K130108

Name: FDA 510(k) clearance K130108
Creator: U.S. Food and Drug Administration
Published: 2013-04-19

Substantially Equivalent

Xiamen Double Engine Medical Material Co., Ltd.

FDA 510(k) clearance K130108 for DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS, Substantially Equivalent on 2013-04-19. Applicant: Xiamen Double Engine Medical Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiamen Double Engine Medical Material Co., Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-01-16
Decision date: 2013-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, Fujian, CN

Download summary PDF View on FDA.gov ↗

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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

More clearances from Xiamen Double Engine Medical Material Co., Ltd.

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K131609 — DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM2014-05-21

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.