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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 12 of 185

Device	Model / Reference	Registries	Class	Status
Calix Spinal Implant System	X034-1230	FDA UDI	Class I	Active
Cortera	150152-55055	FDA UDI	Class II	Active
Cortera	150152-90045	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-80105	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382817-16-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-FX-55-35	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	T085-0015	FDA UDI	Class I	Active
Spider Cervical Plating System	N60000120	FDA UDI	Class II	Active
Cortera	150104-25085	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423015-08PCX	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-0050-S	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-1744	FDA UDI	Class I	Active
Cortera	1505-021150	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-1508	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-90095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-120010	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0397PC-STR	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1360-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0651	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X077-0703	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-S16-30L	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	C080-0087	FDA UDI	Class I	Active
Irix-C Cervical Integrated Fusion System	T066-0152	FDA UDI	Class I	Active
Streamline OCT	26-FTAP-40-16	FDA UDI	Class I	Active
Cortera	150203-55055	FDA UDI	Class II	Active
Cortera	150151-10115	FDA UDI	Class II	Active
VIA DBM Putty, 5cc	DBM005	FDA UDI	Class II	Active
DBM Putty 5.0cc in a Syringe	BM89S5050	FDA UDI	Class II	Active
Cortera	1505-000500	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-10100	FDA UDI	Class II	Active
Streamline OCT	26-REDUCER	FDA UDI	Class I	Active
Cortera	150203-60070	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-60050	FDA UDI	Class II	Active
Cortera	150100-05030	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-PA-75CDY-E	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-LHO-L	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	02-XLNK-FX-CDY-E	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-RS-95-100	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	T073-0320	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0632PC	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion system	C066-0042	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-0169	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-80080	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-55160	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-60090	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0398	FDA UDI	Class II	Unknown
Cortera	150152-85055	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332617-08T	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0330PC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-55105	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.