510(k) Report

FDA applicant

Vertelink Corporation

Mission Viejo, CA3 decisions2003–20030 recalls

FDA records 3 decisions for Vertelink Corporation (Mission Viejo, CA) in 2003: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and EZN (Dilator, Catheter, Ureteral). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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 Vertelink Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vertelink Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vertelink Corporation 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?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • EZNDilator, Catheter, Ureteral1decision
  • DYBIntroducer, Catheter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K032102Vertelink Kobra Spinal Fixation SystemVertelink Corporation · 20031cites it

What has FDA decided for it lately?

  • K032102Vertelink Kobra Spinal Fixation SystemVertelink Corporation · 2003
  • K030734Pathway Access Sheath CatheterVertelink Corporation · 2003
  • K030662Pathway Access Sheath CatheterVertelink Corporation · 2003

All 3 as Vertelink Corporation →