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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 24 of 185

Device	Model / Reference	Registries	Class	Status
X90 Pedicle Screw System	N60000319	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0108-F06-U-STR	FDA UDI	Class II	Active
CuriGraft DBM Putty, 5cc	C024-0005-PTYV	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-60-25	FDA UDI	Class II	Unknown
H-graft Interspinous Allograft	X078-0070	FDA UDI	Class I	Active
Silex Sacroiliac Joint Fusion System	X079-0033	FDA UDI	Class I	Active
Fortilink-A IBF System	65-A-M18-20L-TRL	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X034-1605PC-CS	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X077-0701	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	C079-0058	FDA UDI	Class I	Active
Influx Plus Flow 2.5cc - Syringe	IFLX-FW-02	FDA UDI	Class II	Active
DBM Putty 1.0cc, Axograft	X090-0015-PT1CC	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0060	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-5530-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X077-0414	FDA UDI	Class II	Active
Cortera	150152-95025	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382817-08T	FDA UDI	Class II	Unknown
Cervalign	66-MODDRILL-16	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0312-H04-RU-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-90025	FDA UDI	Class II	Active
Fortex Pedicle Screw System	N60001098	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0251	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60000628	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0009PC	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1500	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X022-0002	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	N60000473	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-332613-08TPC-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-RR-90	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N607555SD-DL	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0851	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-1522	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0312-H06-LU	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-65-45	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	C073-0059	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-140	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0392	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0028	FDA UDI	Class II	Active
OsteoSelect PLUS DBM Putty 5.0cc in a Syringe	359450	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1158	FDA UDI	Class I	Active
Spider Cervical Plating System	N60001520	FDA UDI	Class I	Active
Streamline Tl Spinal Fixation System	02-XLNK-BEND-FIX-R	FDA UDI	Class I	Unknown
Fortilink-A IBF System	65-A-L10-8L-TRL	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-FX-55-30	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-S12-20L-TRL	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-75065	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1185	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0106-F06	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-5545-DL	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-65-85	FDA UDI	Class II	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.