FDA.reportPublic FDA data

Fortilink Cages with TiPlus Technology

Primary DI
08720246785418
Brand
Fortilink Cages with TiPlus Technology
Company
Baat Medical Products B.V.
Model
Fortilink®-TS
Catalog number
67-TS-1026-15-0L
Published
2021-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

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
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
08720246785418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720246785418087202467854188720246785418

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Regulatory Flags#

DUNS number
413205480
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08720246781977Kleiner KG2 systemKG2 Static Parallel 9x24x08x0°02-911082022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520193ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520209ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520216ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520223ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520230ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520247ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520254ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520261ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520278ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520285ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520292ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10