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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 16 of 185

Device	Model / Reference	Registries	Class	Status
Fortex Pedicle Screw System	X022-0192	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-230070	FDA UDI	Class I	Active
Streamline OCT	26-RODTEMP2-120	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150105-05100	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0179PC	FDA UDI	Class II	Active
Cortera	150151-85080	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-82575	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0208-F04-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C010-0085	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-2805	FDA UDI	Class I	Active
Fortex Pedicle Screw System	N60001094	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-65070	FDA UDI	Class II	Active
Streamline OCT	23-CC-ROD-240	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-60020	FDA UDI	Class II	Active
Cervalign	66-MODDRILL-18	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0108-H04-SP	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-TLHANDLE	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150105-70115	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-90110	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-110-90	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150102-25040	FDA UDI	Class II	Active
Cortera	1505-020600	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7575-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0105-DL	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	C066-0084	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-65-100	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150100-10020	FDA UDI	Class II	Active
Streamline OCT	26-COUNTER-T-INLNE	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-332617-08PC	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0088	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-FX-45-40	FDA UDI	Class II	Unknown
InTice™ -C Porous Ti Cervical Interbody System	X098-0209-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-45050	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-020340	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-C-85-65	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-C-55-35	FDA UDI	Class II	Unknown
Streamline MIS Spinal Fixation System	04-55-RR-120	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-1208	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1421	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-0003	FDA UDI	Class I	Active
nanOss 3D Plus Advanced Bone Graft Substitute	90-400-251004	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332615-12T-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-6535SD-DL	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-M08-8L-TRL	FDA UDI	Class I	Unknown
Silex Sacroiliac Joint Fusion System	X079-1255PC-DT	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1641	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332615-08TX	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-FX-65-95	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0101PC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-200160	FDA UDI	Class I	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.