510(k) Report

FDA applicant

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Taichung City, TW3 decisions2022–20260 recalls

FDA records 3 decisions for Taiwan Main Orthopaedic Biotechnology Co., Ltd. (Taichung City, TW) from 2022 to 2026: 3 510(k) clearances. Most are in product codes SBF (Orthopedic Augmented Reality) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 260 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Taiwan Main Orthopaedic Biotechnology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Taiwan Main Orthopaedic Biotechnology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SBFOrthopedic Augmented Reality2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 260 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K254214OoopdsTaiwan Main Orthopaedic Biotechnology Co., Ltd. · 2026
  • K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd. · 2024
  • K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd. · 2022

All 3 as Taiwan Main Orthopaedic Biotechnology Co., Ltd. →