FDA.reportPublic FDA data

LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System

Primary DI
08806344376335
Brand
LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System
Company
L&K BIOMED CO. ,LTD.
Model
3922-3206
Device description
ATP PEEK Cage (L2L5), 6︒,22x45x6mm
Published
2019-01-25
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181380000LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.2018-09-11MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344376335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344376335088063443763358806344376335

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

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
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08809986492807CastleLoc-P Anterior Cervical Plate System6610-4021S2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate System6610-4022S2026-06-09
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08809986479945CastleLoc Pectus Bar SystemPB28-21602026-06-08
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08809986491411CastleLoc-P Anterior Cervical Plate System6913-17632026-06-08
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08809986491473CastleLoc-P Anterior Cervical Plate System6914-17732026-06-08
08809986491480CastleLoc-P Anterior Cervical Plate System6914-17772026-06-08
08809986491497CastleLoc-P Anterior Cervical Plate System6914-17812026-06-08
08809986491503CastleLoc-P Anterior Cervical Plate System6914-17852026-06-08
08809986491510CastleLoc-P Anterior Cervical Plate System6914-17892026-06-08
08809986491527CastleLoc-P Anterior Cervical Plate System6914-17932026-06-08
08809986491534CastleLoc-P Anterior Cervical Plate System6914-17972026-06-08
08809986491541CastleLoc-P Anterior Cervical Plate System6609-35122026-06-08

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