FDA applicant

Scien'Tx USA, Inc.

Austin, TX8 decisions1999–20020 recalls

FDA records 8 decisions for Scien'Tx USA, Inc. (Austin, TX) from 1999 to 2002: 8 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 16 predicates, 3 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 Scien'Tx USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scien'Tx USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scien'Tx USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Scien'Tx USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?