FDA applicant

Spinematrix, Inc.

Philedelphia, PA1 decision2011–20110 recalls

FDA records 1 decision for Spinematrix, Inc. (Philedelphia, PA) in 2011: 1 510(k) clearance. All are in product code IKN (Electromyograph, Diagnostic). 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, physical medicine panel, where it files most

How often FDA has decided Spinematrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Spinematrix, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Spinematrix, Inc.

Which product codes does it file in?

What has FDA decided for it lately?