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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 8 of 185

Device	Model / Reference	Registries	Class	Status
Xspan Laminoplasty Fixation System	X085-0108-U-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150103-45025	FDA UDI	Class II	Active
Cortera	150151-10070	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	X092-091024-5	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X010-0166	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1356-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-05070	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-050450	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-C-55-35	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0180	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423011-12TPC-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-15110	FDA UDI	Class II	Active
Cortera	1506-2920500	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-423011-12	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1009-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0612PC	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-423019-20TR	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-75-65	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-100-70	FDA UDI	Class II	Unknown
Streamline OCT	26-CC-PB-ROD-100	FDA UDI	Class II	Active
Fortilink-TS IBF System	65-TS-13-32	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-1053	FDA UDI	Class I	Active
Zyfix Spinal Facet Screw System	T076-0116	FDA UDI	U	Active
Axle Interspinous Fusion System	X080-382813-08PCX	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-012250	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150204-55120	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0171	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-25100	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0292	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	04-55-RR-160	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-1649	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	T085-0042-06	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7595-DL	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0654	FDA UDI	Class I	Active
Cortera	150100-10060	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0547	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0834	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-70030	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0098	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150315-00070	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1219	FDA UDI	Class I	Active
Cortera	1505-010800	FDA UDI	Class I	Active
Fortilink-A IBF System	65-A-M18-8L	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X080-382817-08PC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-85090	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-60095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150150-90020	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0024	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332615-08T-STR	FDA UDI	Class II	Active
Cortera	150152-55060	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.