FDA applicant

Orthogem Limited

Nottingham, GB3 decisions2007–20150 recalls

FDA records 3 decisions for Orthogem Limited (Nottingham, GB) from 2007 to 2015: 3 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Orthogem, Ltd.”.

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 Orthogem Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Orthogem Limited

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?