510(k) Report

FDA applicant

Arcan Orthopaedic Corp.

Ogden, UT5 decisions1994–19970 recalls

FDA records 5 decisions for Arcan Orthopaedic Corp. (Ogden, UT) from 1994 to 1997: 5 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). 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 Arcan Orthopaedic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arcan Orthopaedic Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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