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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 25 of 185

Device	Model / Reference	Registries	Class	Status
Zyfix Spinal Facet Screw System	T076-0054	FDA UDI	U	Active
Cortera Spinal Fixation System	1509-200200	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0106-F06-U	FDA UDI	Class II	Active
Cortera	150104-65110	FDA UDI	Class II	Active
Cortera	1505-002570	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X077-0519	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0009	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-L12-14L-TRL	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-RS-95-60	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-25100	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0675PC	FDA UDI	Class II	Active
Streamline OCT	26-FTAP-45	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	C080-0037	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-45-35	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150201-60105	FDA UDI	Class II	Active
Cortera	1505-041150	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-82545-DL	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-55-30	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0212	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0633PC	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000609-DL	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-95-60	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X077-0510	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0199	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-TAP-70	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-60-70	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	1505-050750	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0267	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-1207	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	X063-0023	FDA UDI	U	Active
Axle Interspinous Fusion System	X060-0620	FDA UDI	Class II	Active
Cortera	150103-65060	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150200-60060	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0140-CS	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-2809	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-90070	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0252	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1231	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-45-40	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-181406P-PC	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0079	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150105-70085	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1414ST-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-0001	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1691	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150102-70040	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-75-65	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-1227	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0336	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0623	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.