510(k) Report

FDA applicant

K7, LLC

Chesterland, OH3 decisions2013–20140 recalls

FDA records 3 decisions for K7, LLC (Chesterland, OH) from 2013 to 2014: 3 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 26 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 K7, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 22014: 1
2013high 2 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — K7, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like K7, 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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Whose devices does it build on?

Its devices cite 26 predicates; 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.

  • K133126K7 Lumbar SpacersK7, LLC · 20131cites it

What has FDA decided for it lately?

  • K133103Aversion Pedicle Screw SystemK7, LLC · 2014
  • K133126K7 Lumbar SpacersK7, LLC · 2013
  • K123388K7C SpacerK7, LLC · 2013

All 3 as K7, LLC →