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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 28 of 185

Device	Model / Reference	Registries	Class	Status
Cortera	150104-95065	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0306-F06-L-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-400-45	FDA UDI	Class II	Unknown
Cortera	1505-020950	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0206-H06	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382819-12-STRX	FDA UDI	Class II	Active
Zyfix Spinal Facet Screw System	C076-0005	FDA UDI	U	Active
Streamline TL Spinal Fixation System	01-PA-60-65	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-6555	FDA UDI	Class II	Active
Fortilink-C IBF System	65-C-TRL-L-10-6L	FDA UDI	Class I	Unknown
Axle Interspinous Fusion System	X060-0520	FDA UDI	Class I	Active
Cortera	1505-003130	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-75-55	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	C060-0061	FDA UDI	Class I	Active
Atrix-C Cervical Allograft Spacer	X094-0003	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150307-55602	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-75-45	FDA UDI	Class II	Unknown
X-port Minimally Invasive Set	X014-0020	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	02-HOOKHOLDER-I	FDA UDI	Class I	Unknown
Fortilink-TS IBF System	65-TS-TRL22-10	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-C-85-100	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	T085-0041	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-6545	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	C066-0130	FDA UDI	Class I	Active
Cortera	1506-2920350	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-65070	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0057	FDA UDI	Class I	Active
OsteoPore Plus DBM Putty 10.0cc Syringe	SC-5210-DBM	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423015-08	FDA UDI	Class II	Active
Cervalign	66-112	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000620-DL	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0220PC	FDA UDI	Class II	Active
Spider Cervical Plating System	CN60-0029	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150105-85115	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-60095	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1656	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	02-FINALDRIVER	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150101-95025	FDA UDI	Class II	Active
Cortera	150150-95055	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0248PC-STR	FDA UDI	Class II	Active
Cortera	150103-95045	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181406TL-PC	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-6540SD-DL	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423013-08PCX	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-05085	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	T073-1200	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0024-DL	FDA UDI	Class II	Active
Cortera	150150-90060	FDA UDI	Class II	Active
Cortera	150104-05090	FDA UDI	Class II	Active
Cortera	150104-70100	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.