FDA.reportPublic FDA data

VertebraLINK

Primary DI
00817329023753
Brand
VertebraLINK
Company
LINKSPINE, INC.
Model
84-0520/0007
Catalog number
84-0520/0007
Device description
7mm Spreader/Shaver
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817329023753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329023753008173290237538173290237530817329023753

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
067584601
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
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07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
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07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
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07613327262070O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262087O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262094O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262100CENTAURStryker CorporationLXH2019-11-25
07613327262285XIAStryker CorporationLXH2019-11-25
07613327263176XIA IIStryker CorporationLXH2019-11-25
07613327263183XIA IIStryker CorporationLXH2019-11-25
07613327263190XIA IIStryker CorporationLXH2019-11-25
07613327263220XIA IIStryker CorporationLXH2019-11-25