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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 47 of 185

Device	Model / Reference	Registries	Class	Status
Cervalign	66-FST-45-18	FDA UDI	Class II	Active
DBM Putty 10.0cc	LD-600-010-M	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-55190	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000337-DL	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-55-40	FDA UDI	Class II	Unknown
Cortera	150151-15095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-85110	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-15120	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-60115	FDA UDI	Class II	Active
Cortera	150151-80065	FDA UDI	Class II	Active
Streamline OCT	23-NUTDRIVER	FDA UDI	Class I	Active
Calix Spinal Implant System	X003-0615	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332617-20-STR	FDA UDI	Class II	Active
DBM Putty 0.5cc	BX-600-005-M	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	04-EXTREMPLIER	FDA UDI	Class I	Unknown
Certex Spinal Fixation System	X067-0468	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150204-55170	FDA UDI	Class II	Active
X90 Pedicle Screw System	N605550SD-DL	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	X092-121024	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-M20-30L	FDA UDI	Class II	Unknown
Cortera	1505-040950	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-10075	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000626	FDA UDI	Class II	Active
Cortera	150151-20075	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-0035	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0560	FDA UDI	Class II	Unknown
Cortera	150200-55115	FDA UDI	Class II	Active
Cortera	150151-65105	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-55-RR-350	FDA UDI	Class II	Unknown
Cortera	150151-05120	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-55025	FDA UDI	Class II	Active
Cortera	150151-75065	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-80090	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0104	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150105-95075	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332615-08T	FDA UDI	Class II	Unknown
Cortera	150103-50050	FDA UDI	Class II	Active
Cortera	150103-95040	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-423017-24T-STR	FDA UDI	Class II	Active
nanOss 3D Plus Advanced Bone Graft Substitute	90-400-251008	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	723-731	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	10-55-PR-45	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	C080-0072-16	FDA UDI	Class I	Active
Calix Spinal Implant System	X003-0654	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1548	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	X073-7545	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-1250-DT	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	05-SCREWSLEEVE	FDA UDI	Class I	Unknown
Certex Spinal Fixation System	X067-1680	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-161308L	FDA UDI	Class II	Active

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.