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Xtant Medical Holdings, Inc.

Last updated September 17, 2026

What Xtant Medical Holdings, Inc. makes

Xtant Medical Holdings, Inc. manufactures spinal devices including non-bioabsorbable spinal bone screws, polymeric and metallic spinal interbody fusion cages, non-bioabsorbable spinal fixation plates, bone-screw internal spinal fixation systems, bone taps, and interspinous spinal fixation implants. Specific products include the Streamline OCT, Cortera, Xspan Laminoplasty Fixation System, InTice™ -C Porous Ti Cervical Interbody System, Aranax Anterior Cervical Plating System, Calix Spinal Implant System, Fortex Pedicle Screw System, Cortera Spinal Fixation System, and Zyfix Spinal Facet Screw System.

The company's portfolio is regulated with devices classified as Class I, Class II, and U, and is listed in the FDA UDI registry. Xtant Medical Holdings, Inc. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Xtant Medical Holdings, Inc. manufacture?

Where is Xtant Medical Holdings, Inc. based?

Xtant Medical Holdings, Inc. is based in the US, as indicated in the device data provided.

Which registries list Xtant Medical's devices?

Xtant Medical's devices are listed in the FDA UDI registry, as specified in the device data.

How are Xtant Medical's devices classified?

Xtant Medical's devices are classified as Class I, Class II, and U, according to the regulatory classifications provided in the device data.

AI-generated from registry data and not verified by a human reviewer.

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 49 of 185

Device	Model / Reference	Registries	Class	Status
Streamline OCT	26-FNLDRIVER	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-2706	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-80-45	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X080-382815-12T-STR	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-6038LX	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150100-45020	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0395LM	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-382813-12TPC	FDA UDI	Class II	Unknown
DBM Putty 5.0cc	GRA-P5	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0036	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-0123	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0387PC-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-70-65	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-00070	FDA UDI	Class II	Active
Streamline OCT	26-PA-45-30	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-332613-16TR	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0254	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161306TP-PC	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0052	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-95-60	FDA UDI	Class II	Unknown
Cortera	150103-80045	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-55-RR-100	FDA UDI	Class II	Unknown
Calix Spinal Implant System	C034-0229	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0420	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0710	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1520	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	C080-0019	FDA UDI	Class I	Active
Aranax Anterior Cervical Plating System	T086-1654	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-0007	FDA UDI	Class I	Active
Xsert Lumbar Expandable Interbody System	T092-0900-1	FDA UDI	Class I	Unknown
Xpress Minimally Invasive Pedicle Screw System	X073-0010	FDA UDI	Class II	Active
Cortera	150103-65030	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000619	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332615-08PC-STR	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	C066-0011	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-7555C-DL	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0666	FDA UDI	Class I	Active
Fortilink-TC IBF System	65-TC-T32-13-6L	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150106-25075	FDA UDI	Class II	Active
Cortera	150100-45055	FDA UDI	Class II	Active
Cortera	150151-65065	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X070-0010	FDA UDI	Class II	Active
Cortera	150152-75040	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0038	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150101-90040	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150203-55155	FDA UDI	Class II	Active
Fortex Pedicle Screw System	C022-0022	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150209-60135	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0940	FDA UDI	Class I	Active
Streamline® TL Spinal Fixation System	02-CONNECT-BAR-400	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

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Authorities

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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.

Xtant Medical Holdings, Inc. has 5 recall records, with the earliest initiated on 2023-11-28 and the most recent on 2026-03-09. The statuses recorded are open and classified. The reasons given include incorrect labeling of shelf life, incorrect screw dimensions and labeling, incorrect expiration date, mislabeled part numbers, and implants marked 'DNI' that are not intended for implantation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.