FDA.reportPublic FDA data

Fortilink-C IBF System

Primary DI
00840311212767
Brand
Fortilink-C IBF System
Company
Xtant Medical Holdings, Inc.
Model
65-C-1012-10-6L
Catalog number
65-C-1012-10-6L
Device description
Fortilink-C, 10x12, 10mm, 6L
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163673000Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.2017-05-23ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468080310PreviousGS10
00840311212767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468080310008464680803108464680803100846468080310
00840311212767008403112127678403112127670840311212767

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311224425Cortera Spinal Fixation System150211-553002026-05-18
00840311224432Cortera Spinal Fixation System150211-554002026-05-18
00840311224449Cortera Spinal Fixation System150211-555002026-05-18
00840311224456Cortera Spinal Fixation System150211-556002026-05-18
00840311224463Cortera Spinal Fixation System150211-603002026-05-18
00840311224470Cortera Spinal Fixation System150211-604002026-05-18
00840311224487Cortera Spinal Fixation System150211-605002026-05-18
00840311224494Cortera Spinal Fixation System150211-606002026-05-18
00840311227181Cortera Spinal Fixation System150220-553002026-05-18
00840311227198Cortera Spinal Fixation System150220-554002026-05-18
00840311227204Cortera Spinal Fixation System150220-555002026-05-18
00840311227211Cortera Spinal Fixation System150220-556002026-05-18
00840311227228Cortera Spinal Fixation System150220-603002026-05-18
00840311227235Cortera Spinal Fixation System150220-604002026-05-18
00840311227242Cortera Spinal Fixation System150220-605002026-05-18
00840311227259Cortera Spinal Fixation System150220-606002026-05-18
00840311212774Fortilink-C IBF System65-C-1012-11-6L65-C-1012-11-6L2026-04-30
00840311212798Fortilink-C IBF System65-C-1012-6-6L65-C-1012-6-6L2026-04-30
00840311212804Fortilink-C IBF System65-C-1012-7-6L65-C-1012-7-6L2026-04-30
00840311212828Fortilink-C IBF System65-C-1012-9-6L65-C-1012-9-6L2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
07640140433813icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mmicotec AGODP2018-07-16
07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16
07640140433837icotec Cervical Cage, Anatomic Probe, 7 mm x 13 mmicotec AGODP2018-07-16
07640140433875icotec Cervical Cage, Anatomic Probe, 5 mm x 16 mmicotec AGODP2018-07-16
07640140433882icotec Cervical Cage, Anatomic Probe, 6 mm x 16 mmicotec AGODP2018-07-16
07640140433899icotec Cervical Cage, Anatomic Probe, 7 mm x 16 mmicotec AGODP2018-07-16
07640140433905icotec Cervical Cage, Anatomic Probe, 8 mm x 16 mmicotec AGODP2018-07-16
07640140438900icotec Cervical Cage, Anatomic Probe, 5 mm x 18 mmicotec AGODP2018-07-16
07640140438917icotec Cervical Cage, Anatomic Probe, 6 mm x 18 mmicotec AGODP2018-07-16
07640140438924icotec Cervical Cage, Anatomic Probe, 7 mm x 18 mmicotec AGODP2018-07-16
07640140438931icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mmicotec AGODP2018-07-16
07640140438948icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2018-07-16
07640164840949icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container, completeicotec AGODP2018-07-16
07640164840956icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Baseicotec AGODP2018-07-16
07640164840963icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Lidicotec AGODP2018-07-16
07640164840970icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Inlay 1/2icotec AGODP2018-07-16
07640164840987icotec Lumbar Cage, Lumbar Cage PLIF, Container, completeicotec AGODP2018-07-16
07640164840994icotec Lumbar Cage, Lumbar Cage PLIF, Container Baseicotec AGODP2018-07-16
07640164841007icotec Lumbar Cage, Lumbar Cage PLIF, Container Lidicotec AGODP2018-07-16
07640164841014icotec Lumbar Cage, Lumbar Cage PLIF, Container Inlay 1/2icotec AGODP2018-07-16
07640164841342icotec Lumbar Cage, Extractoricotec AGODP2018-07-16
07640164841359icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 6 mmicotec AGODP2018-07-16
07640164841366icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 7 mmicotec AGODP2018-07-16
07640164841373icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 9 mmicotec AGODP2018-07-16
07640164841380icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 11 mmicotec AGODP2018-07-16
07640164841397icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 13 mmicotec AGODP2018-07-16