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

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
00840311245390Streamline® MIS Spinal Fixation System04-CANNTAP-4004-CANNTAP-402026-03-18
00840311245406Streamline® MIS Spinal Fixation System04-CANNTAP-4504-CANNTAP-452026-03-18
00840311245437Streamline® MIS Spinal Fixation System04-CANNTAP-7504-CANNTAP-752026-03-18
00840311245642Streamline® MIS Spinal Fixation System04-RDSETSCR-INS04-RDSETSCR-INS2026-03-18
00840311245703Streamline® MIS Spinal Fixation System04-SEQDILATOR-104-SEQDILATOR-12026-03-18
00840311245710Streamline® MIS Spinal Fixation System04-SEQDILATOR-204-SEQDILATOR-22026-03-18
00840311245727Streamline® MIS Spinal Fixation System04-SEQDILATOR-304-SEQDILATOR-32026-03-18
00840311245734Streamline® MIS Spinal Fixation System04-SEQDILATOR-404-SEQDILATOR-42026-03-18
00840311245741Streamline® MIS Spinal Fixation System04-SETSCREWINS04-SETSCREWINS2026-03-18
00840311245925Streamline® MIS Spinal Fixation System05-CT-TUBE05-CT-TUBE2026-03-18
00840311245932Streamline MIS Spinal Fixation System05-DILATOR05-DILATOR2026-04-30
00840311245956Streamline® MIS Spinal Fixation System05-FINALDRIVER05-FINALDRIVER2026-03-18
00840311245963Streamline® MIS Spinal Fixation System05-FINALDRIVER205-FINALDRIVER22026-03-18
00840311246700Streamline® MIS Spinal Fixation System05-TAPSLEEVE05-TAPSLEEVE2026-03-18
00840311246755Streamline MIS Spinal Fixation System51-GW-500-BLUNT51-GW-500-BLUNT2026-04-30
00840311246762Streamline MIS Spinal Fixation System51-GW-500-BLUNT-SS51-GW-500-BLUNT-SS2026-04-30
00840311246779Streamline MIS Spinal Fixation System51-GW-500-BLUNT-TH51-GW-500-BLUNT-TH2026-04-30
00840311246786Streamline MIS Spinal Fixation System51-GW-500-SHARP51-GW-500-SHARP2026-04-30
00840311246793Streamline MIS Spinal Fixation System51-GW-500-SHARP-SS51-GW-500-SHARP-SS2026-04-30
00840311246809Streamline MIS Spinal Fixation System51-GW-500-SHARP-TH51-GW-500-SHARP-TH2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522201S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522202S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522203S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522204S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522205S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522206S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26