510(k) Report

FDA applicant

A-Spine Asia, Co., Ltd.

Taipei, Neihu District, TW1 decision2011–20110 recalls

FDA records 1 decision for A-Spine Asia, Co., Ltd. (Taipei, Neihu District, TW) in 2011: 1 510(k) clearance. All are in product code MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 10 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, orthopedic panel, where it files most

How often FDA has decided A-Spine Asia, Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — A-Spine Asia, Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like A-Spine Asia, Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd. · 20112cite it

What has FDA decided for it lately?

  • K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd. · 2011

The one decision as A-Spine Asia, Co., Ltd. →