FDA.reportPublic FDA data

Fortilink

Primary DI
04260636678936
Brand
Fortilink
Company
Xtant Medical Holdings, Inc.
Model
65-C-INS-TIPLUS
Device description
Fortilink-C TiPlus Inserter, Housing
Published
2022-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213493000Fortilink with TiPlus TechnologyParadigm Spine2022-01-27ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260636678936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260636678936042606366789364260636678936

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(844) 894-7752customerservice@surgalign.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
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000704452MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
18257200076871FORZAOrthofix US LLCMAX2026-07-17
18257200076888FORZAOrthofix US LLCMAX2026-07-17
18257200076895FORZAOrthofix US LLCMAX2026-07-17
18257200076901FORZAOrthofix US LLCMAX2026-07-17
18257200076918FORZAOrthofix US LLCMAX2026-07-17
18257200076925FORZAOrthofix US LLCMAX2026-07-17
18257200077007FORZAOrthofix US LLCMAX2026-07-17
18257200077038FORZAOrthofix US LLCMAX2026-07-17
18257200106028FORZAOrthofix US LLCMAX2026-07-17
18257200106035FORZAOrthofix US LLCMAX2026-07-17
18257200106042FORZAOrthofix US LLCMAX2026-07-17
18257200106066FORZAOrthofix US LLCMAX2026-07-17
18257200106073FORZAOrthofix US LLCMAX2026-07-17
18257200106080FORZAOrthofix US LLCMAX2026-07-17
18257200106097FORZAOrthofix US LLCMAX2026-07-17
18257200106103FORZAOrthofix US LLCMAX2026-07-17
18257200106141FORZAOrthofix US LLCMAX2026-07-17
18257200106158FORZAOrthofix US LLCMAX2026-07-17
18257200109432FORZA PTCOrthofix US LLCMAX2026-07-17
18257200136056FORZA XPOrthofix US LLCMAX2026-07-17
18257200136063FORZA XPOrthofix US LLCMAX2026-07-17
18257200136070FORZA XPOrthofix US LLCMAX2026-07-17
18257200151769FORZA TiOrthofix US LLCMAX2026-07-17