FDA.reportPublic FDA data

LnK Spinal Fixation System

Primary DI
08806189837459
Brand
LnK Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1052-50370
Catalog number
1052-50370
Device description
L&K Biomed Rod, Straight, Hex, Titanium 5.0x370mm 1EA
Published
2015-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08806189837459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189837459088061898374598806189837459

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986488718CastleLoc Pectus Bar System Instrument SetPB02-00012026-03-09
08809986488725CastleLoc Pectus Bar System Instrument SetPB01-00702026-03-09
08809986488732CastleLoc Pectus Bar System Instrument SetPB01-0003S2026-03-09
08809986488749CastleLoc Pectus Bar System Instrument SetPB01-08022026-03-09
08809986488756CastleLoc Pectus Bar System Instrument SetPB01-10022026-03-09
08809986488763CastleLoc Pectus Bar System Instrument SetPB01-12022026-03-09
08809986488770CastleLoc Pectus Bar System Instrument SetPB01-14022026-03-09
08809986488787CastleLoc Pectus Bar System Instrument SetPB01-16022026-03-09
08809986488794CastleLoc Pectus Bar System Instrument SetPB01-0069L2026-03-09
08809986488800CastleLoc Pectus Bar System Instrument SetPB01-0001S2026-03-09
08809986488817CastleLoc Pectus Bar System Instrument SetPB01-0001M2026-03-09
08809986488824CastleLoc Pectus Bar System Instrument SetPB01-0001L2026-03-09
08809986488831CastleLoc Pectus Bar System Instrument SetPB01-0002S2026-03-09
08809986488848CastleLoc Pectus Bar System Instrument SetPB01-0002M2026-03-09
08809986488855CastleLoc Pectus Bar System Instrument SetPB01-0002L2026-03-09
08809986488862CastleLoc Pectus Bar System Instrument SetPB02-0001S2026-03-09
08809986488879CastleLoc Pectus Bar System Instrument SetPB02-0001M2026-03-09
08809986488886CastleLoc Pectus Bar System Instrument SetPB02-0001L2026-03-09
08809986488893CastleLoc Pectus Bar System Instrument SetPB02-0002S2026-03-09
08809986488909CastleLoc Pectus Bar System Instrument SetPB02-0002M2026-03-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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 SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
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