FDA.reportPublic FDA data

LnK Basic Spinal Fixation System

Primary DI
08806189884569
Brand
LnK Basic Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
PS24-7545
Catalog number
PS24-7545
Device description
L&K Biomed Cannulted Reductionn Poly Axial Screw 7.5x45mm 1EA
Published
2015-05-13
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189884569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189884569088061898845698806189884569

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
08809986479907LnK Spinal Instrument SystemCM0141-CC022026-05-12
08809986479914LnK Spinal Instrument SystemCM146-CS02-03012026-05-12
08809986479921LnK Spinal Instrument SystemCM146-CS02-03022026-05-12
08809986469991LnK Spinal Instrument SystemCM0142-PT012026-04-30
08809986489296LnK Spinal Instrument SystemLP01-07022026-04-29
08809986489302LnK Spinal Instrument SystemLP01-07042026-04-29
08809986489319LnK Spinal Instrument SystemLP01-07052026-04-29
08806344399808LnK Spinal Instrument SystemLS03-CM612026-04-16
08809986482815CastleLoc Pectus Bar SystemOB28-01102026-04-17
08809986482822CastleLoc Pectus Bar SystemOB28-01152026-04-17
08809986482839CastleLoc Pectus Bar SystemOB28-01202026-04-17
08809986482846CastleLoc Pectus Bar SystemOB28-01252026-04-17
08809986482853CastleLoc Pectus Bar SystemOB28-01302026-04-17
08809986482860CastleLoc Pectus Bar SystemOB28-01352026-04-17
08809986469878LnK Spinal Instrument SystemBR05-00082026-04-16
08809986469885LnK Spinal Instrument SystemBR05-00092026-04-16
08809986479860LnK Spinal Instrument SystemBT01-90012026-04-16
08809986479877LnK Spinal Instrument SystemBT01-90022026-04-16
08809986479884LnK Spinal Instrument SystemBT01-90032026-04-16
08809986479891LnK Spinal Instrument SystemBT01-90042026-04-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
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00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
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00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNH2018-08-17
00841732118959PICASSO IICTL Medical CorporationMNH2017-08-08
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