510(k) Report

FDA applicant

Eminent Spine

Plano, TX15 decisions2009–20252 recalls

FDA records 15 decisions for Eminent Spine (Plano, TX) from 2009 to 2025: 15 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 53 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Eminent Spine, LLC”.

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

FDA decisions per year

2in 2025

2009: 22010: 12011: 12014: 12015: 12020: 12021: 12022: 12023: 22024: 22025: 2
2009high 2 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2013

2013: 2
2009high 2 (2013) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Eminent Spine by year, 2009–2026Sources: 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 Body4decisions
  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • OURSacroiliac Joint Fixation2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Also: OVE (1), OVD (1), HRS (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 53 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 59 times; 7 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.

  • K090064Eminent Spine Interbody Fusion SystemEminent Spine · 200934cite it
  • K212853Cervical Stand-Alone SystemEminent Spine, LLC · 20215cite it
  • K100377Diamondback Spinal SystemEminent Spine · 20104cite it
  • K090415Eminent Spine Buttress (Fang) Plate SystemEminent Spine · 20093cite it
  • K133194Diamond Rattlesnake SystemEminent Spine · 20143cite it
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 20232cite it

What has FDA decided for it lately?

  • K250894Eminent Spine Posterior SI SystemEminent Spine · 2025
  • K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
  • K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine · 2024
  • K240505Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
  • K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
  • K221936Standalone ALIF Interbody Fusion SystemEminent Spine · 2022
  • K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021

All 11 as Eminent Spine →All 4 as Eminent Spine, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090415Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of…Feb 20, 2013Class II
  • K090064Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD…Feb 20, 2013Class II