FDA applicant
Arcan Orthopaedic Corp.
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
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.
Planning a device like Arcan Orthopaedic Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report