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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 7 of 185

Device	Model / Reference	Registries	Class	Status
Irix-A Lumbar Integrated Fusion System	X080-423011-08PC-STRX	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0011	FDA UDI	Class II	Active
Calix Spinal Implant System	C003-0009	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60000339	FDA UDI	Class II	Active
Spider Cervical Plating System	N60000177	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	10-SHANDLE	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150101-55060	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-55040	FDA UDI	Class II	Active
Cortera	150100-10025	FDA UDI	Class II	Active
Cortera	150103-85035	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-20065	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0007	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-382819-16T-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C073-0004	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0220	FDA UDI	Class II	Active
Cortera	150151-75120	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-0007-CS	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	04-PA-95-55	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-775-75	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-95105	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-60170	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-010010	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150101-95055	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150200-60065	FDA UDI	Class II	Active
Cortera	150150-85030	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-200030	FDA UDI	Class I	Active
Streamline® MIS Spinal Fixation System	04-TAP-75	FDA UDI	Class I	Unknown
Streamline® MIS Spinal Fixation System	04-CANNTAP-70	FDA UDI	Class I	Unknown
Streamline MIS Spinal Fixation System	04-PA-85-100	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X080-382815-12PC	FDA UDI	Class II	Active
Cervalign	66-122	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	C066-0010	FDA UDI	Class I	Active
Cortera	1505-000320	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	T080-0100-6	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-75-100	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	02-COMPTIP-S-L	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-15075	FDA UDI	Class II	Active
Streamline® TL Spinal Fixation System	02-TOWER	FDA UDI	Class I	Unknown
Cortera	150151-80080	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-75-40	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1685	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-1232	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1070	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0243	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0260	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-M10-14L-TRL	FDA UDI	Class I	Unknown
Fortilink-A IBF System	65-A-M22-30L-TRL	FDA UDI	Class I	Unknown
Fortilink-A IBF System	65-A-L08-8L	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150209-55160	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0331	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.