FDA.reportPublic FDA data

Fortilink Cages with TiPlus Technology

Primary DI
08720246789980
Brand
Fortilink Cages with TiPlus Technology
Company
Baat Medical Products B.V.
Model
Fortilink®-SA
Catalog number
68-A-3627-12-20L
Device description
Anterior Lumbar Cage
Published
2023-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201453000Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH2020-10-07MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720246789980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720246789980087202467899808720246789980

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] 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 included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413205480
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720246785418Fortilink Cages with TiPlus TechnologyFortilink®-TS67-TS-1026-15-0L2021-11-25
08720629951256SDS Growing RodSDS Growing RodSDS55ROD2026-03-30
08720629951287SDS Growing RodSDS Growing RodSDS55BUT2026-03-30
08720629951300SDS Growing RodSDS Growing RodSDS55ASB2026-03-30
08720629951324SDS Growing RodSDS Growing RodSDS55PSB2026-03-30
08720629951478SDS Growing RodSDS Growing RodSDSLOCK2026-03-30
08720629951485SDS Growing RodSDS Growing RodSDSCOMPR2026-03-30
08720629958750SDS Growing RodSDS Growing RodSDS55CCL2026-03-30
08720629958767SDS Growing RodSDS Growing RodSDS55S1002026-03-30
08720629958828SDS Growing RodSDS Growing RodSDSTHAN92026-03-30
08720629959573SINEFIXPunch600072026-04-01
08721515510151SINEFIXSINEFIX300012026-04-01
08720629951492SDS Growing RodSDS Growing RodSDSDRIVER2026-03-30
08720629951508SDS Growing RodSDS Growing RodSDSTRAY2026-03-30
08720629958774SDS Growing RodSDS Growing RodSDSFORC2026-03-30
08720629950464SINEFIXSINEFIX300012023-04-11
08720629950532SINEFIXRepusher400072023-04-11
08720629950549SINEFIXTray400082023-04-11
08720629959177SINEFIXSINEFIX Easy Grip600022025-07-03
08720246781960Kleiner KG2 systemKG2 Static Parallel 9x24x07x0° 02-911072022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982313524ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313531ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313548ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313555ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313562ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00889095311532INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311549INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311556INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311563INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311570INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311587INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19