FDA applicant

Bm Korea Co., Ltd.

Fullerton, CA6 decisions2011–20150 recalls

FDA records 6 decisions for Bm Korea Co., Ltd. (Fullerton, CA) from 2011 to 2015: 6 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and NDN (Cement, Bone, Vertebroplasty). Its devices cite 30 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bm Korea”.

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 Bm Korea Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2011high 2 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Bm Korea Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bm Korea Co., Ltd.’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

Bm Korea Co., Ltd.

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?