FDA applicant

Osteo Vasive, LLC

San Diego, CA1 decision2014–20142 recalls

FDA records 1 decision for Osteo Vasive, LLC (San Diego, CA) in 2014: 1 510(k) clearance. All are in product code OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 9 predicates, 0 of them its own earlier devices. 2 recalls are 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 Osteo Vasive, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2019

2014high 2 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Osteo Vasive, 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 “Osteo”

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

Osteo Technology, Inc. 18 Osteo AG 9 Osteo-Technology Intl., Inc. 3 Osteo Implant Corp. 2

Osteo Vasive, LLC

Which product codes does it file in?

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Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Osteo”