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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005031160
DUNS Number: —

Catalogue (9214)

Page 19 of 185

Device	Model / Reference	Registries	Class	Status
Streamline TL Spinal Fixation System	01-PA-65-40	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-0170	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0062	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-7535	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0730	FDA UDI	Class I	Active
Cortera	150103-65050	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0039	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-65-80	FDA UDI	Class II	Unknown
Silex Sacroiliac Joint Fusion System	X079-0007PC-CS	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-1230	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-10080	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-6550SD	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150200-60050	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-85-50	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-C-45-40	FDA UDI	Class II	Unknown
Cortera	150103-60040	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0631PC	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	C079-0266	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-382813-08-STRX	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-55-55	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0386LM	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-875-75	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60000350-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-47540-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0101	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C073-0065	FDA UDI	Class II	Active
Spider Cervical Plating System	N60001500	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0106-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-25070	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0306-F04-R	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-75-70	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	X073-6595-DL	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	X063-0055	FDA UDI	U	Active
X90 Pedicle Screw System	N60000602	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0212-H04	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0217	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0244	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1206	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60000275	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-7535-DL	FDA UDI	Class II	Active
Cortera	150150-50025	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0406-STR	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-332615-24TR	FDA UDI	Class I	Active
Spider Cervical Plating System	N60000150	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-115-60	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-S10-14L-TRL	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	10-55-RR-80	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0244	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0342	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0443	FDA UDI	Class I	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.