510(k) Report

FDA applicant

Luitpold Pharmaceuticals, Inc.

Washington, DC2 decisions1999–20110 recalls

FDA records 2 decisions for Luitpold Pharmaceuticals, Inc. (Washington, DC) from 1999 to 2011: 2 510(k) clearances. Most are in product codes LYC (Bone Grafting Material, Synthetic) and NPM (Bone Grafting Material, Animal Source). Its devices cite 4 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, dental panel, where it files most

How often FDA has decided Luitpold Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Luitpold Pharmaceuticals, Inc. 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?

  • LYCBone Grafting Material, Synthetic1decision
  • NPMBone Grafting Material, Animal Source1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K111816EquimatrixLuitpold Pharmaceuticals, Inc. · 20111cites it

What has FDA decided for it lately?

  • K111816EquimatrixLuitpold Pharmaceuticals, Inc. · 2011
  • K990537Osteo-Pin Membrane Fixation PinLuitpold Pharmaceuticals, Inc. · 1999

All 2 as Luitpold Pharmaceuticals, Inc. →