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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 31 of 185

Device	Model / Reference	Registries	Class	Status
Streamline TL Spinal Fixation System	10-55-RR-70	FDA UDI	Class II	Unknown
DBM Putty 2.5cc	GRA-P2	FDA UDI	Class II	Active
Cortera	150150-75060	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-S16-8L-TRL	FDA UDI	Class I	Unknown
Streamline MIS Spinal Fixation System	05-PA-65-50	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	X085-0106-H04-SP-STR	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0121	FDA UDI	Class I	Active
Streamline OCT	26-HA-40-46	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0023	FDA UDI	Class II	Active
Cortera	150104-15100	FDA UDI	Class II	Active
Cortera	150100-70040	FDA UDI	Class II	Active
Cortera	150104-75080	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-60180	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161306TL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X010-0153	FDA UDI	Class II	Active
Cortera	150100-55050	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-BENDER-55	FDA UDI	Class I	Unknown
Cervalign	66-580	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382819-12T	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X077-0402	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-70065	FDA UDI	Class II	Active
Cortera	150150-50055	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1238	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332619-12TPC	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0151	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-7535SD	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-0076	FDA UDI	Class I	Active
Calix Spinal Implant System	X003-0617	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-70070	FDA UDI	Class II	Active
Cervalign	66-232	FDA UDI	Class II	Active
Cortera	150151-90065	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0026	FDA UDI	Class II	Unknown
Zyfix Spinal Facet Screw System	X076-0034	FDA UDI	U	Active
Spider Cervical Plating System	N60000118	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-10115	FDA UDI	Class II	Active
Streamline OCT	26-ROCKER	FDA UDI	Class I	Active
Streamline OCT	26-CC-PB-ROD-85	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0510-STR	FDA UDI	Class II	Active
Streamline OCT	26-3255-CLSD-11	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-60055	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1652	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150209-55155	FDA UDI	Class II	Active
Cortera	150151-00110	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-105	FDA UDI	Class II	Unknown
Cortera	150150-95025	FDA UDI	Class II	Active
Fortilink-C IBF System	65-C-TRL-S-9-6L	FDA UDI	Class I	Unknown
Axle Interspinous Fusion System	C060-0079	FDA UDI	Class I	Active
Calix Spinal Implant System	C034-0232	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-423019-20PC-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1695	FDA UDI	Class II	Unknown

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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.