510(k) Report

FDA applicant

Korea Bone Bank Co., Ltd.

Brea, CA3 decisions2008–20120 recalls

FDA records 3 decisions for Korea Bone Bank Co., Ltd. (Brea, CA) from 2008 to 2012: 3 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 5 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 Korea Bone Bank Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008: 12011: 12012: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Korea Bone Bank Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K082509Eos Spinal SystemKorea Bone Bank Co., Ltd. · 20084cite it
  • K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd. · 20121cites it
  • K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd. · 20111cites it

What has FDA decided for it lately?

  • K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd. · 2012
  • K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd. · 2011
  • K082509Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008

All 3 as Korea Bone Bank Co., Ltd. →