510(k) Report

FDA applicant

Spine Next America

Queenstown, MD5 decisions2004–20040 recalls

FDA records 5 decisions for Spine Next America (Queenstown, MD) in 2004: 5 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spine Next America Corporation”.

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 Spine Next America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spine Next America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spine Next America 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?

  • MNIOrthosis, Spinal Pedicle Fixation2decisions
  • MQPSpinal Vertebral Body Replacement Device2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 20043cite it

What has FDA decided for it lately?

  • K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation · 2004
  • K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 2004
  • K033965Shiraz-Anterior SystemSpine Next America · 2004
  • K033947Shiraz Posterior SystemSpine Next America · 2004
  • K033772Shiraz-Java Spinal Fixation SystemSpine Next America · 2004

All 3 as Spine Next America →All 2 as Spine Next America Corporation →