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Xtant Medical Holdings, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 664 Cruiser Lane, Belgrade, MT, 59714
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005031160
DUNS Number: —

Catalogue (9214)

Page 14 of 185

Device	Model / Reference	Registries	Class	Status
Cortera Spinal Fixation System	150102-70050	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0278	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0366	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-2726	FDA UDI	Class I	Active
Streamline® MIS Spinal Fixation System	04-TAP-60	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	10-PUSHER	FDA UDI	Class I	Unknown
X-port Minimally Invasive Set	X014-0052	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-423017-16PC-STR	FDA UDI	Class II	Active
Cervalign	66-116	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0132	FDA UDI	Class II	Unknown
Xsert Lumbar Expandable Interbody System	X092-091026-STR	FDA UDI	Class II	Unknown
Cervalign	66-5100	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0210-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-47550-DL	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382819-16-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0085-DL	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423013-12PCX	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-82550-DL	FDA UDI	Class II	Active
Xsert Lumbar Expandable Fusion System	T092-0600-2	FDA UDI	Class I	Unknown
Streamline OCT	23-CC-ROD-20	FDA UDI	Class II	Active
Streamline OCT	23-CC-ROD-120	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-65055	FDA UDI	Class II	Active
Fortilink-C	65-C-1214-8-6L	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0275	FDA UDI	Class II	Unknown
Streamline OCT	26-OCPS-45-10	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-AWL	FDA UDI	Class I	Unknown
Fortex Pedicle Screw System	N60000471	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C073-0089	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0390	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150106-10070	FDA UDI	Class II	Active
Cortera	150151-70080	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-M12-8L-TRL	FDA UDI	Class I	Unknown
Streamline OCT	26-OFFSETCONN-S	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0006	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-05110	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0082-DL	FDA UDI	Class II	Active
Spider Cervical Plating System	N60001502	FDA UDI	Class I	Active
Cortera Spinal Fixation System	1509-200070	FDA UDI	Class I	Active
Streamline OCT	26-PA-45-14	FDA UDI	Class II	Active
Streamline OCT	26-OCPRATCHET	FDA UDI	Class I	Active
Cervalign	66-MODTAP-16	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-C-45-25	FDA UDI	Class II	Unknown
Aranax Anterior Cervical Plating System	X086-1140-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-7530SD-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-051150	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1316	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1073	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-423017-08PC-STRX	FDA UDI	Class II	Active
Spider Cervical Plating System	N60000152	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0010	FDA UDI	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 9, 2026	Z-1897-2026	—	open, classified	Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Feb 18, 2026	Z-1773-2026	—	open, classified	Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Jan 3, 2025	Z-1177-2025	—	open, classified	Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Aug 21, 2024	Z-0125-2025	—	open, classified	Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Nov 28, 2023	Z-0846-2024	—	open, classified	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.