FDA.reportPublic FDA data

Fortilink-C

Primary DI
00840311262816
Brand
Fortilink-C
Company
Xtant Medical Holdings, Inc.
Model
C999-000006-08
Device description
SPECIAL TRIAL SPACER, 14.5X17X8MM
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

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
00840311262816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311262816008403112628168403112628160840311262816

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-886-9354CS@XTANTMEDICAL.COM

Regulatory Flags#

DUNS number
081224143
Device count
1
Lot or batch
true
Sterilization required before use
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
00889024713840G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713857G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713864G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713871G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
10603295555643INHANCEDEPUY ORTHOPAEDICS, INC.HWT2026-11-03
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29
04260056886287InterSpace® Knee Mold Trial Tibial StemOSARTIS GmbHHWT2026-10-29
04260056886416InterSpace® Knee Mold Trial Tibial InsertOSARTIS GmbHHWT2026-10-29
04260056886423InterSpace® Knee Mold Trial Tibial Stemmed InsertOSARTIS GmbHHWT2026-10-29
00889024702493OsseoFitZimmer, Inc.HWT2026-10-27