510(k) Report

FDA applicant

Ossacur AG

Santa Barbara, CA4 decisions2004–20060 recalls

FDA records 4 decisions for Ossacur AG (Santa Barbara, CA) from 2004 to 2006: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 12 predicates, 3 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 Ossacur AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ossacur AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ossacur AG 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?

  • MQVFiller, Bone Void, Calcium Compound3decisions
  • LYCBone Grafting Material, Synthetic1decision

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 20062cite it
  • K042305Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML…Ossacur AG · 20042cite it
  • K050416Ossaplast OrthoOssacur AG · 20051cites it

What has FDA decided for it lately?

  • K051047Colloss E Bone Void FillerOssacur AG · 2006
  • K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006
  • K050416Ossaplast OrthoOssacur AG · 2005
  • K042305Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML…Ossacur AG · 2004

All 4 as Ossacur AG →