FDA.reportPublic FDA data

LnK Spinal Fixation System

Primary DI
08806189866237
Brand
LnK Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1902-6215
Catalog number
1902-6215
Device description
L&K Biomed Lateral Connector, Closed L1:26, L2:15, W:10,D1:6 1EA
Published
2015-05-12
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
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189866237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189866237088061898662378806189866237

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at each end, into which screw heads/rods fit, 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 transverse connecting element to be attached to corresponding bilateral screw heads or rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
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03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03