Xtant Medical Holdings, Inc.
Xtant Medical Holdings, Inc. holds FDA 510(k) medical device clearance, cleared in 2024, with 5 FDA device recalls on record.
Top product codes for Xtant Medical Holdings, Inc.
FDA recalls by Xtant Medical Holdings, Inc.
- Z-1897-2026 — nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc
- Z-1773-2026 — XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Z-1177-2025 — Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
- Z-0125-2025 — Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
- Z-0846-2024 — Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Xtant Medical Holdings, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.