510(k) Report

FDA applicant

Spinenet, LLC

Winter Park, FL2 decisions2011–20201 recall

FDA records 2 decisions for Spinenet, LLC (Winter Park, FL) from 2011 to 2020: 2 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 6 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 Spinenet, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12020: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Spinenet, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K110733Daytona Anterior Cervical CageSpinenet, LLC · 20115cite it

What has FDA decided for it lately?

  • K200170SpineNet SSP SystemSpinenet, LLC · 2020
  • K110733Daytona Anterior Cervical CageSpinenet, LLC · 20111 recall

All 2 as Spinenet, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110733SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona…Feb 5, 2013Class II