510(k) Report

FDA applicant

Qualgenix

Oxford, CT4 decisions2012–20120 recalls

FDA records 4 decisions for Qualgenix (Oxford, CT) in 2012: 4 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 21 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Qualgenix, 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 Qualgenix’s devices, and how often a recall has named them.

FDA decisions per year

4in 2012

2012: 4
2012high 4 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

Planning a device like Qualgenix’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 21 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K112801Ayers Rock Cervical CageQualgenix · 20122cite it
  • K112684Mont Blanc Pedicle Screw SystemsQualgenix · 20121cites it
  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 20121cites it

What has FDA decided for it lately?

  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012
  • K112684Mont Blanc Pedicle Screw SystemsQualgenix · 2012
  • K112801Ayers Rock Cervical CageQualgenix · 2012
  • K112696Twin Peaks Lumbar CageQualgenix, LLC · 2012

All 2 as Qualgenix →All 2 as Qualgenix, LLC →