510(k) Report

FDA applicant

Orthogen, LLC

Springfield, NJ2 decisions2001–20110 recalls

FDA records 2 decisions for Orthogen, LLC (Springfield, NJ) from 2001 to 2011: 2 510(k) clearances. All are in product code LYC (Bone Grafting Material, Synthetic). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Orthogen Corp.”.

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 Orthogen, LLC’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 — Orthogen, LLC 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, Synthetic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K011403Surgiplaster Calcium Sulfate HemihydrateOrthogen Corp. · 20013cite it

What has FDA decided for it lately?

  • K102208NanogenOrthogen, LLC · 2011
  • K011403Surgiplaster Calcium Sulfate HemihydrateOrthogen Corp. · 2001

The one decision as Orthogen, LLC →The one decision as Orthogen Corp. →