FDA applicant

Etex Corp.

Cambridge, MA25 decisions1992–20240 recalls

FDA records 25 decisions for Etex Corp. (Cambridge, MA) from 1992 to 2024: 25 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 55 predicates, 39 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Etex Corporation”, “Etex Co.”.

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 Etex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 5 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Etex Corp.’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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Etex Corp.

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?