FDA applicant

Scient'X USA, Inc.

Round Rock, TX4 decisions2003–20090 recalls

FDA records 4 decisions for Scient'X USA, Inc. (Round Rock, TX) from 2003 to 2009: 4 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 2 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 Scient'X USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scient'X USA, Inc.’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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Other applicant names beginning “Scient'X”

FDA records each applicant name separately; these may or may not be the same firm.

Scient'X 12

Scient'X 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?

Other applicant names beginning “Scient'X”