Never miss a competitor's FDA clearance. FDA orthopedic 510(k) clearances for this applicant, in
chronological order. K-numbers link to the official FDA record.
2clearances tracked
2026-08-28first in this archive
2026-09-17most recent
2product codes
First clearance in this archive: 2026-08-28 —
K261830, FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog).
Archive coverage is decisions 2026-08-26 to 2026-09-27; “first in this
archive” is scoped to that coverage and is not a claim about this
applicant’s first-ever FDA clearance.
FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)