510(k) Report

FDA applicant

Resofix, Inc.

Oviedo, FL1 decision2005–20050 recalls

FDA records 1 decision for Resofix, Inc. (Oviedo, FL) in 2005: 1 510(k) clearance. All are in product code HTN (Washer, Bolt Nut). 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 Resofix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Resofix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HTNWasher, Bolt Nut1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K043411Resofix Bioabsorbable Expansion BoltResofix, Inc. · 20051cites it

What has FDA decided for it lately?

  • K043411Resofix Bioabsorbable Expansion BoltResofix, Inc. · 2005

The one decision as Resofix, Inc. →