510(k) Report

FDA applicant

Eden Spine, LLC

Apple Valley, MN2 decisions2012–20161 recall

FDA records 2 decisions for Eden Spine, LLC (Apple Valley, MN) from 2012 to 2016: 2 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2012high 1 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Eden Spine, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQPSpinal Vertebral Body Replacement Device1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC · 20121cites it

What has FDA decided for it lately?

  • K160982Sphynx™Eden Spine, LLC · 2016
  • K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC · 20121 recall

All 2 as Eden Spine, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K112429GIZA Vertebral Body ReplacementMar 17, 2017Class II