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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 5 of 185

Device	Model / Reference	Registries	Class	Status
Zyfix Spinal Facet Screw System	T076-0065	FDA UDI	U	Active
Silex Sacroiliac Joint Fusion System	C079-0001	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-15120	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-RL-115	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1615LM	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X022-0197	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150100-95020	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	X092-071032-STR	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-423011-12PC-STRX	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0047	FDA UDI	Class I	Active
Cervalign	66-MODTAP-10	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150103-45035	FDA UDI	Class II	Active
Cortera	150104-00115	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-60-50	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0368	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-70-50	FDA UDI	Class II	Unknown
Streamline® MIS Spinal Fixation System	51-GW-500-BLUNT-TH	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0466	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X080-332619-12X	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-020060	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-85095	FDA UDI	Class II	Active
Cortera	150203-60035	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0082	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0060	FDA UDI	Class I	Active
Cortera	150104-75120	FDA UDI	Class II	Active
Butrex Buttress Plating System	X023-0005	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-L16-14L	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150100-65020	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-1260-DT	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1223	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1051	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-0120-CR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1673	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-80-80	FDA UDI	Class II	Unknown
Streamline MIS Spinal Fixation System	04-PA-45-35	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150106-15115	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-60170	FDA UDI	Class II	Active
Cortera	150100-25030	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-55-55	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-161307L	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-2889	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-60-55	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-95-50	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	10-55-PR-100	FDA UDI	Class II	Unknown
Calix Spinal Implant System	C034-0245	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-0083	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	T085-0030	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0127LM	FDA UDI	Class II	Unknown
Cortera	150103-90055	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-75105	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.