510(k) Report

FDA applicant

Spine Next SA

Queenstown, MD3 decisions2003–20030 recalls

FDA records 3 decisions for Spine Next SA (Queenstown, MD) in 2003: 3 510(k) clearances. Most are in product codes JDK (Prosthesis, Hip, Cement Restrictor) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Spine Next SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spine Next SA 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?

  • JDKProsthesis, Hip, Cement Restrictor2decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030871Fidji Large Cement RestrictorSpine Next SA · 20031cites it

What has FDA decided for it lately?

  • K030767Fidji Small Cement RestrictorSpine Next SA · 2003
  • K030871Fidji Large Cement RestrictorSpine Next SA · 2003
  • K031265Shiraz-Java Spinal Fixation SystemSpine Next SA · 2003

All 3 as Spine Next SA →