FDA.reportPublic FDA data

LnK Basic Spinal Fixation System

Primary DI
08806189886747
Brand
LnK Basic Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
2912-5550
Catalog number
2912-5550
Device description
L&K Biomed MIS Poly Axial Screw, Closed 5.5x50mm 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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189886747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189886747088061898867478806189886747

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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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