FDA.reportPublic FDA data

LnK Spinal Fixation System

Primary DI
08806189835172
Brand
LnK Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1071-55280
Catalog number
1071-55280
Device description
L&K Biomed Rod, Straight, CoCrMo 6.0x280mm 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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189835172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189835172088061898351728806189835172

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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 designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
00840283402203VyPlate™VY SPINE LLCKWQ2026-03-19
08800071055440ASTEROSTEONIC CO.,Ltd.KWQ2026-03-19
00763000889982VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000889999VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890001VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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00763000890117VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890124VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890131VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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