OOOPDS— 510(k) K254214

Name: FDA 510(k) clearance K254214
Creator: U.S. Food and Drug Administration
Published: 2026-09-15

Substantially Equivalent

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

FDA 510(k) clearance K254214 for OOOPDS, Substantially Equivalent on 2026-09-15. Applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-29
Decision date: 2026-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

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K242271 — Caduceus S2024-10-30
K220554 — Caduceus S2022-12-16

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.