510(k) Report

FDA applicant

Elute, Inc.

Salt Lake City, UT2 decisions2018–20250 recalls

FDA records 2 decisions for Elute, Inc. (Salt Lake City, UT) from 2018 to 2025: 2 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 3 predicates, 1 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 Elute, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12025: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Elute, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180853EP Granules™ BVFElute, Inc. · 20181cites it

What has FDA decided for it lately?

  • K250346BonVie+Elute, Inc. · 2025
  • K180853EP Granules™ BVFElute, Inc. · 2018

All 2 as Elute, Inc. →