5 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·April 15, 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
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·April 29, 2026
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))
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·February 26, 2025
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·October 23, 2024
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·February 7, 2024