510(k) Report

FDA applicant

CG Bio Co., Ltd.

Seoul, KR6 decisions2013–20260 recalls

FDA records 6 decisions for CG Bio Co., Ltd. (Seoul, KR) from 2013 to 2026: 6 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 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 CG Bio Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12016: 12023: 12025: 12026 (partial year): 2
2013high 2 (2026) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — CG Bio Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like CG Bio 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?

  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • OMPNegative Pressure Wound Therapy Powered Suction Pump2decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 20164cite it
  • K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 20232cite it

What has FDA decided for it lately?

  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026
  • K252251Easymade-TICG Bio Co., Ltd. · 2026
  • K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025
  • K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K122490KulavacCG Bio Co., Ltd. · 2013

All 6 as CG Bio Co., Ltd. →