510(k) Report

FDA applicant

Advanced Spinal Technologies, Inc.

Boca Raton, FL1 decision2005–20050 recalls

FDA records 1 decision for Advanced Spinal Technologies, Inc. (Boca Raton, FL) in 2005: 1 510(k) clearance. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 4 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

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

FDA decisions per year

No FDA decision for Advanced Spinal Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Spinal Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LXMManipulator, Plunger-Like Joint1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050428Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)Advanced Spinal Technologies, Inc. · 2005

The one decision as Advanced Spinal Technologies, Inc. →