FDA.reportPublic FDA data

LnK Posterior Cervical Fixation System

Primary DI
08806189878742
Brand
LnK Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6133-1805
Catalog number
6133-1805
Device description
L&K Biomed Cervical HOOK 18mm 1EA
Published
2015-05-14
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
KWPAppliance, Fixation, Spinal Interlaminal
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189878742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189878742088061898787428806189878742

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

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
08809986490001CastleLoc Pectus Bar SystemPB28-01752026-05-27
08809986490018CastleLoc Pectus Bar SystemPB28-01802026-05-27
08809986490025CastleLoc Pectus Bar SystemPB28-01852026-05-27
08809986490032CastleLoc Pectus Bar SystemPB28-01902026-05-27
08809986490049CastleLoc Pectus Bar SystemPB28-01952026-05-27
08809986490056CastleLoc Pectus Bar SystemPB28-02002026-05-27
08809986490063CastleLoc Pectus Bar SystemPB30-01752026-05-27
08809986490087CastleLoc Pectus Bar SystemPB30-01852026-05-27
08809986490094CastleLoc Pectus Bar SystemPB30-01902026-05-27
08809986490100CastleLoc Pectus Bar SystemPB30-01952026-05-27
08809986490117CastleLoc Pectus Bar SystemPB30-02002026-05-27
08809986490124CastleLoc Pectus Bar SystemPB28-11752026-05-27
08809986490131CastleLoc Pectus Bar SystemPB28-11802026-05-27
08809986490148CastleLoc Pectus Bar SystemPB28-11852026-05-27
08809986490155CastleLoc Pectus Bar SystemPB28-11902026-05-27
08809986490162CastleLoc Pectus Bar SystemPB28-11952026-05-27
08809986490179CastleLoc Pectus Bar SystemPB28-12002026-05-27
08809986490186CastleLoc Pectus Bar SystemPB30-11752026-05-27
08809986490193CastleLoc Pectus Bar SystemPB30-11802026-05-27
08809986490209CastleLoc Pectus Bar SystemPB30-11852026-05-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153143741XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationMNI2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationMNI2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045861XIA IIStryker CorporationMNI2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationMNI2014-12-08