FDA.reportPublic FDA data

VertebraLINK

Primary DI
00817329021209
Brand
VertebraLINK
Company
LINKSPINE, INC.
Model
84-0004/0606
Catalog number
84-0004/0606
Device description
8 x 30 x 6 x 6 PLIF IBD
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K162693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162693000VertebraLINK Fusion PlatformFacetlink Dba Linkspine2017-03-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817329021209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329021209008173290212098173290212090817329021209

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA 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) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height6Millimeter
Length30Millimeter
Width8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-410-772-5465cs@linkspine.com

Regulatory Flags#

DUNS number
067584601
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817329024248CorticaLINK80-452680-45262018-04-25
00817329020004CorticaLINK80-400180-40012016-09-30
00817329020011CorticaLINK80-4002/02580-4002/0252016-09-30
00817329020028CorticaLINK80-4002/03080-4002/0302016-09-30
00817329020035CorticaLINK80-4002/03580-4002/0352016-09-30
00817329020042CorticaLINK80-4002/04080-4002/0402016-09-30
00817329020059CorticaLINK80-4002/05080-4002/0502016-09-30
00817329020066CorticaLINK80-4002/06080-4002/0602016-09-30
00817329020073CorticaLINK80-4002/07080-4002/0702016-09-30
00817329020080CorticaLINK80-4002/10080-4002/1002016-09-30
00817329020097CorticaLINK80-4003/02580-4003/0252016-09-30
00817329020103CorticaLINK80-4003/03080-4003/0302016-09-30
00817329020110CorticaLINK80-4003/03580-4003/0352016-09-30
00817329020127CorticaLINK80-4003/04080-4003/0402016-09-30
00817329020134CorticaLINK80-4003/05080-4003/0502016-09-30
00817329020141CorticaLINK80-4003/06080-4003/0602016-09-30
00817329020158CorticaLINK80-4003/07080-4003/0702016-09-30
00817329020165CorticaLINK80-4003/10080-4003/1002016-09-30
00817329020172CorticaLINK80-4006/452580-4006/45252016-09-30
00817329020189CorticaLINK80-4006/453080-4006/45302016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02