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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 15 of 185

Device	Model / Reference	Registries	Class	Status
Xpress Minimally Invasive Pedicle Screw System	C010-0086	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	724-624	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	10-55-PR-RL-35	FDA UDI	Class II	Unknown
Calix Spinal Implant System	C003-0036	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0108-SP-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-70100	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0096	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0973	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0791	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0072-17	FDA UDI	Class I	Active
Fortilink-TS IBF System	65-TS-14-22	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X022-0195	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-00065	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0033	FDA UDI	Class II	Unknown
Zyfix Spinal Facet Screw System	X076-0024	FDA UDI	U	Active
Fortilink-A IBF System	65-A-S20-20L-TRL	FDA UDI	Class I	Unknown
Certex Spinal Fixation System	X067-0121LM	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1035	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-20105	FDA UDI	Class II	Active
Cortera	150150-50045	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	C079-0053	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0391PC	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-65-55	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0242	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-75-75	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-1428PC	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0396	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-80075	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	X063-0029	FDA UDI	U	Active
Axle Interspinous Fusion System	X060-0545	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0241	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	T092-1500	FDA UDI	Class I	Unknown
Axle Interspinous Fusion System	X060-1213	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0673	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000620	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1317	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1423PC	FDA UDI	Class II	Active
Cortera	150103-70060	FDA UDI	Class II	Active
Streamline® TL Spinal Fixation System	02-ADJUSTER	FDA UDI	Class I	Unknown
Cortera	150104-65100	FDA UDI	Class II	Active
Cortera	150150-10055	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0306-F06-R-STR	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0811	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	T073-0330	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-75020	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	04-CANNTAP-80	FDA UDI	Class I	Unknown
Irix-A Lumbar Integrated Fusion System	X080-423019-24-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-75-35	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	X073-7530	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-RS-55CDY-E	FDA UDI	Class I	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.