FDA applicant

Osseon, LLC

Santa Rosa, CA3 decisions2014–20150 recalls

FDA records 3 decisions for Osseon, LLC (Santa Rosa, CA) from 2014 to 2015: 3 510(k) clearances. All are in product code NDN (Cement, Bone, Vertebroplasty). Its devices cite 4 predicates, 2 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 Osseon, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014high 2 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Osseon, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Osseon”

FDA records each applicant name separately; these may or may not be the same firm.

Osseon Therapeutics, Inc. 1

Osseon, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Osseon”