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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 23 of 185

Device	Model / Reference	Registries	Class	Status
Cortera	1505-030450	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-6550C	FDA UDI	Class II	Active
nanOss 3D Plus Advanced Bone Graft Substitute	90-400-25504	FDA UDI	Class II	Active
Cortera	150203-55105	FDA UDI	Class II	Active
H-graft Interspinous Allograft	X078-0112	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-7550SD	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0244PC-STR	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423015-08X	FDA UDI	Class II	Active
Spider Cervical Plating System	CN60-0030	FDA UDI	Class I	Active
Calix-C Cervical Interbody Spacer	C003-0050	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60001038	FDA UDI	Class II	Active
Cortera	1505-001890	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-85090	FDA UDI	Class II	Active
Cortera	1505-002090	FDA UDI	Class I	Active
Cortera	1505-002300	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0540	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	1505-050700	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0201	FDA UDI	Class II	Unknown
Cortera	150203-60045	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0016	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-3514ST	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1636LM	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	02-COMPTIP-O-L	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-25110	FDA UDI	Class II	Active
Streamline OCT	26-FDRILL-35-16	FDA UDI	Class I	Active
Cortera	150100-90040	FDA UDI	Class II	Active
Cervalign	66-FIXED-GUIDE	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0308-H04-RU-STR	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1131-STR	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161309L-PC	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-SCREWDIST	FDA UDI	Class I	Unknown
Irix-A Lumbar Integrated Fusion System	X080-423019-12-STRX	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1057	FDA UDI	Class II	Active
Reficio DBM Crunch 2.5cc	27912318	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-65-90	FDA UDI	Class II	Unknown
Streamline OCT	26-PA-45-26	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-2870	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-423019-20-STR	FDA UDI	Class II	Active
Streamline OCT	26-OCPDRVR	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-65-65	FDA UDI	Class II	Unknown
Streamline® MIS Spinal Fixation System	04-TAP-55	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-875-80	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-1059	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-C-85-55	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-65105	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332613-12TPCX	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-382815-12-STRX	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-1255PC	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	T085-0020-08	FDA UDI	Class I	Active
Cortera	150150-75030	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.