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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 13 of 185

Device	Model / Reference	Registries	Class	Status
Cortera Spinal Fixation System	150105-10070	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-60040	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0076	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-FXL-31	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	T085-0015-2-06	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	T073-1500	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-00115	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332619-08T-STR	FDA UDI	Class II	Active
Cortera	150104-70105	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0100	FDA UDI	Class II	Active
Isto Plus Flow 10.0cc - Syringe	ISTO-FW-10	FDA UDI	Class II	Active
Cortera	150152-55030	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0134	FDA UDI	Class I	Active
Cervalign	66-VST-40-18	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-75075	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0136	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1511	FDA UDI	Class II	Unknown
Cortera	150100-15055	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-4015	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60000622-DL	FDA UDI	Class II	Active
Cortera	1505-020450	FDA UDI	Class I	Active
Cortera	150150-25030	FDA UDI	Class II	Active
Cortera	150150-80040	FDA UDI	Class II	Active
Cortera	150150-75035	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	05-THRDREDUCER	FDA UDI	Class I	Unknown
Streamline OCT	26-PA-SS-40-38	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-55135	FDA UDI	Class II	Active
Cortera	150150-20030	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-0234-CS	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1648	FDA UDI	Class II	Active
Beast Plus	P01-DBM-3050	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0959	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150313-00200	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	T073-1310	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-50-30	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-90100	FDA UDI	Class II	Active
Cortera	150100-15045	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-0053	FDA UDI	Class I	Active
Cortera	150151-00085	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0794	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-90120	FDA UDI	Class II	Active
Streamline OCT	26-COUNTER-T	FDA UDI	Class I	Active
Cortera	150152-60055	FDA UDI	Class II	Active
Fortex Pedicle Screw System	C010-0088	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332611-08	FDA UDI	Class II	Active
Cortera	150151-90075	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000917	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-M20-20L	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	02-95SCREW-CDY	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X034-0248PC	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.