FDA.reportPublic FDA data

VertebraLINK

Primary DI
00817329023821
Brand
VertebraLINK
Company
LINKSPINE, INC.
Model
84-0520/0014
Catalog number
84-0520/0014
Device description
14mm 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
OTC
false
Sterile
false
Single use
false

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
00817329023821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817329023821008173290238218173290238210817329023821

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817329023500VertebraLINK84-0501/0084-0501/002018-04-24
00817329023517VertebraLINK84-0501/5084-0501/502018-04-24
00817329023555VertebraLINK84-0505/040184-0505/04012018-04-24
00817329023562VertebraLINK84-0505/040284-0505/04022018-04-24
00817329023579VertebraLINK84-0505/040384-0505/04032018-04-24
00817329023586VertebraLINK84-0505/060184-0505/06012018-04-24
00817329023593VertebraLINK84-0505/060284-0505/06022018-04-24
00817329023609VertebraLINK84-0505/060384-0505/06032018-04-24
00817329023616VertebraLINK84-050684-05062018-04-24
00817329023623VertebraLINK84-0508/L84-0508/L2018-04-24
00817329023630VertebraLINK84-0508/R84-0508/R2018-04-24
00817329023647VertebraLINK84-0509/L84-0509/L2018-04-24
00817329023654VertebraLINK84-0509/R84-0509/R2018-04-24
00817329020004CorticaLINK80-400180-40012016-09-30
00817329020011CorticaLINK80-4002/02580-4002/0252016-09-30
00817329020028CorticaLINK80-4002/03080-4002/0302016-09-30
00817329020042CorticaLINK80-4002/04080-4002/0402016-09-30
00817329020097CorticaLINK80-4003/02580-4003/0252016-09-30
00817329020103CorticaLINK80-4003/03080-4003/0302016-09-30
00817329020127CorticaLINK80-4003/04080-4003/0402016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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