FDA.reportPublic FDA data

Pro-Link Ti

Primary DI
00190837031527
Brand
Pro-Link Ti
Company
Life Spine, Inc.
Model
23-1411-710T
Catalog number
23-1411-710T
Published
2019-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180642000Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.2018-05-10OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837031527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837031527001908370315271908370315270190837031527

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837124137Arx17-8575-032026-04-17
00190837124144Arx17-8580-032026-04-17
00190837124151Arx17-8585-032026-04-17
00190837124168Arx17-8590-032026-04-17
00190837124175Arx17-8595-032026-04-17
00190837124243Arx17-9525-032026-04-17
00190837124250Arx17-9530-032026-04-17
00190837124267Arx17-9535-032026-04-17
00190837124274Arx17-9540-032026-04-17
00190837124281Arx17-9545-032026-04-17
00190837124298Arx17-9550-032026-04-17
00190837124304Arx17-9555-032026-04-17
00190837124311Arx17-9560-032026-04-17
00190837124397Arx17-95100-032026-04-17
00190837124403Arx17-95105-032026-04-17
00190837124410Arx17-95110-032026-04-17
00190837124427Arx17-95115-032026-04-17
00190837124434Arx17-95120-032026-04-17
00190837125912Arx17-8575-132026-04-17
00190837125929Arx17-8580-132026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10195860030438E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030551E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030568E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030575E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030582E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030599E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030605E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030612E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030674E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030704E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030728E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030742E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030766E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030780E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030803E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030810E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030827E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030834E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030841E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030858E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030889E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030896E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030919E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030926E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030964E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20