510(k) Report

FDA applicant

Spine Works

Traverse City, MI1 decision2001–20010 recalls

FDA records 1 decision for Spine Works (Traverse City, MI) in 2001: 1 510(k) clearance. All are in product code HAX (Tong, Skull For Traction). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Spine Works since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spine Works 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?

  • HAXTong, Skull For Traction1decision

What has FDA decided for it lately?

  • K003662Spine Works CollarSpine Works · 2001

The one decision as Spine Works →