FDA.reportPublic FDA data

Lnk Spinal Fixation System

Primary DI
08806189800040
Brand
Lnk Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1304-0000
Catalog number
1304-0000
Device description
L&K Biomed Set Screw-Star for 6.0 Rod 9.7x5.6mm 1EA
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWGProsthesis, Finger, Constrained, Metal/Polymer
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWGProsthesis, Finger, Constrained, Metal/PolymerOrthopedic3
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189800040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189800040088061898000408806189800040

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986482440CastleLoc Pectus Bar SystemPF12-20222026-08-25
08809986482457CastleLoc Pectus Bar SystemPF12-23122026-08-25
08809986482464CastleLoc Pectus Bar SystemPF12-23152026-08-25
08809986482471CastleLoc Pectus Bar SystemPF12-23182026-08-25
08809986482488CastleLoc Pectus Bar SystemPF12-23222026-08-25
08809986482495CastleLoc Pectus Bar SystemPF12-25182026-08-25
08809986481894CastleLoc Pectus Bar SystemPB25-E1602026-08-21
08809986481900CastleLoc Pectus Bar SystemPB25-E1652026-08-21
08809986481917CastleLoc Pectus Bar SystemPB25-E1702026-08-21
08809986481924CastleLoc Pectus Bar SystemPB10-00032026-08-21
08809986481931CastleLoc Pectus Bar SystemPB10-00072026-08-21
08809986481948CastleLoc Pectus Bar SystemPB10-00082026-08-21
08809986481955CastleLoc Pectus Bar SystemPB10-00092026-08-21
08809986481962CastleLoc Pectus Bar SystemPB10-00102026-08-21
08809986481979CastleLoc Pectus Bar SystemPB10-00112026-08-21
08809986481986CastleLoc Pectus Bar SystemPB10-00122026-08-21
08809986481993CastleLoc Pectus Bar SystemPB10-00132026-08-21
08809986482006CastleLoc Pectus Bar SystemPB10-00142026-08-21
08809986482013CastleLoc Pectus Bar SystemPB10-00152026-08-21
08809986482020CastleLoc Pectus Bar SystemPB10-00162026-08-21

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