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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 26 of 185

Device	Model / Reference	Registries	Class	Status
DBM Putty 2.5cc in a Syringe	BM89S5025	FDA UDI	Class II	Active
Cortera	1505-000432	FDA UDI	Class I	Active
Cervalign	66-460	FDA UDI	Class II	Active
Cortera	150203-60170	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0287	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-90105	FDA UDI	Class II	Active
Zyfix Spinal Facet Screw System	T076-0040-2	FDA UDI	U	Active
Streamline TL Spinal Fixation System	01-PA-C-85-90	FDA UDI	Class II	Unknown
Cortera	1505-000602	FDA UDI	Class I	Active
Cortera	150104-05120	FDA UDI	Class II	Active
Cortera	150103-60050	FDA UDI	Class II	Active
Cortera	150104-90105	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-6530C-DL	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0331PC	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0085	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7555	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-382817-08X	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0100-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X077-0408	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0373	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150204-55050	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-423015-12PC-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0979	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0294	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-S12-14L	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1622	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150204-55055	FDA UDI	Class II	Active
Cortera	1505-002520	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-0017-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-200110	FDA UDI	Class I	Active
Cortera	150104-65115	FDA UDI	Class II	Active
Cortera	150100-10035	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-0100-19	FDA UDI	Class I	Active
Irix-C Cervical Integrated Fusion System	X066-161312TL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0008	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-423017-12TPC	FDA UDI	Class II	Unknown
Calix Spinal Implant System	C034-0224	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-0097-DL	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0120PC	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0042	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-1250PC-DT	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X010-0150	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000605-DL	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-PA-L-85CDY-E	FDA UDI	Class I	Unknown
Streamline OCT	26-OCPS-45-9	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-75095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-55100	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-05070	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-85-35	FDA UDI	Class II	Unknown
Cortera	150150-90040	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.