FDA.reportPublic FDA data

MIDLINE II-Ti

Primary DI
00840402508250
Brand
MIDLINE II-Ti
Company
Silony Medical GmbH
Model
M422116c
Catalog number
M422116c
Device description
MIDLINE II-Ti 42mm x 21mm x 16°
Published
2025-11-24
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
K141942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141942000MIDLINE II TICentinel Spine, Inc.2014-11-07OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101021959PreviousGS10
00840402508250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101021959008151010219598151010219590815101021959
00840402508250008404025082508404025082500840402508250

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite 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 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 device made of a non-bioabsorbable synthetic polymer with a metallic coating 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312969760
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054896000770AwlVI-1010VI-10102026-09-18
04054896000787AwlVI-1020VI-10202026-09-18
04054896000831Control GaugesVI-1040VI-10402026-09-18
04054896000855Implant ModifierVI-1160VI-11602026-09-18
04054896000862Implant ModifierVI-1250VI-12502026-09-18
04054896000879Implant ModifierVI-1270VI-12702026-09-18
04054896000886Forceps and ClampsVI-1320VI-13202026-09-18
04054896000893(Re-) Positioning ToolsVI-1340VI-13402026-09-18
04054896000909(Re-) Positioning ToolsVI-1360VI-13602026-09-18
04054896000916(Re-) Positioning ToolsVI-1361VI-13612026-09-18
04054896000923AdapterVI-1362VI-13622026-09-18
04054896000930(Re-) Positioning ToolsVI-1363VI-13632026-09-18
04054896000947AdapterVI-1410VI-14102026-09-18
04054896000985Torque LimiterVI-1450VI-14502026-09-18
04054896000992(Re-) Positioning ToolsVI-1510VI-15102026-09-18
04054896001005Forceps and ClampsVI-1530VI-15302026-09-18
04054896001012Implant ModifierVI-1610VI-16102026-09-18
04054896001029Forceps and ClampsVI-1620VI-16202026-09-18
04054896001036Forceps and ClampsVI-1630VI-16302026-09-18
04054896001067Forceps and ClampsVI-1820VI-18202026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046202AVS PLStryker CorporationOVD2015-09-14
07613153046219AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046233AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationOVD2015-09-14
07613153046332AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14