510(k) Report

FDA applicant

Spineselect, LLC

Apple Valley, MN2 decisions2008–20140 recalls

FDA records 2 decisions for Spineselect, LLC (Apple Valley, MN) from 2008 to 2014: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 6 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 Spineselect, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12014: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Spineselect, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K080058Turbo Prime Ibd SystemSpineselect, LLC · 20081cites it

What has FDA decided for it lately?

  • K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC · 2014
  • K080058Turbo Prime Ibd SystemSpineselect, LLC · 2008

All 2 as Spineselect, LLC →