FDA applicant

Osteogenics, Inc.

Burlington, WI6 decisions1996–20071 recall

FDA records 6 decisions for Osteogenics, Inc. (Burlington, WI) from 1996 to 2007: 6 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and LYC (Bone Grafting Material, Synthetic). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Osteogenics Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Osteogenics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osteogenics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Osteogenics”

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

Osteogenics Biomedical, Inc. 8 Osteogenics Biomedical, Inc. (Formerly Obi Biologi 1

Osteogenics, Inc.

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?

What has been recalled?

Other applicant names beginning “Osteogenics”