510(k) Report

FDA applicant

Effortmed, LLC

Coral Springs, FL3 decisions2024–20250 recalls

FDA records 3 decisions for Effortmed, LLC (Coral Springs, FL) from 2024 to 2025: 3 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 42 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 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 Effortmed, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 12025: 2
2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Effortmed, LLC by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Effortmed, LLC’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
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 42 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 64 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 20251cites it
  • K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 20251cites it

What has FDA decided for it lately?

  • K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
  • K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
  • K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC · 2024

All 3 as Effortmed, LLC →