510(k) Report

FDA applicant

Coligne AG

Zurich, CH4 decisions2017–20210 recalls

FDA records 4 decisions for Coligne AG (Zurich, CH) from 2017 to 2021: 4 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 0 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 Coligne AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12018: 22021: 1
2017high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Coligne AG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coligne AG’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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • PLRSpinal Vertebral Body Replacement Device - Cervical1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 110 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K173148ACIFColigne AG · 20171cites it
  • K181963ostaPek Interbody Fusion CagesColigne AG · 20181cites it

What has FDA decided for it lately?

  • K210306GII Spinal Fixation SystemColigne AG · 2021
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K173893TrabisColigne AG · 2018
  • K173148ACIFColigne AG · 2017

All 4 as Coligne AG →