FDA.reportPublic FDA data

LnK Lumbar Interbody Fusion Cage System

Primary DI
08806189874324
Brand
LnK Lumbar Interbody Fusion Cage System
Company
L&K BIOMED CO. ,LTD.
Model
3718-2417
Catalog number
3718-2417
Device description
L&K Biomed ALIF PEEK Cage 24x 32 8 17mm 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
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
K110783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110783000VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGEL&K BIOMED Co., Ltd.2011-10-24MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806189874324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806189874324088061898743248806189874324

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
Primary DIBrandModelCatalogPublished
08809986491008BluEX Cervical Expandable Cage System1417-1000S2026-06-04
08809986491015BluEX Cervical Expandable Cage System1417-1100S2026-06-04
08809986491022BluEX Cervical Expandable Cage System1417-1200S2026-06-04
08809986491039BluEX Cervical Expandable Cage System1417-1300S2026-06-04
08809986491046BluEX Cervical Expandable Cage System1417-0407S2026-06-04
08809986491053BluEX Cervical Expandable Cage System1417-0507S2026-06-04
08809986491060BluEX Cervical Expandable Cage System1417-0607S2026-06-04
08809986491077BluEX Cervical Expandable Cage System1417-0707S2026-06-04
08809986491084BluEX Cervical Expandable Cage System1417-0807S2026-06-04
08809986491091BluEX Cervical Expandable Cage System1417-0907S2026-06-04
08809986491107BluEX Cervical Expandable Cage System1417-1007S2026-06-04
08809986491114BluEX Cervical Expandable Cage System1417-1107S2026-06-04
08809986491121BluEX Cervical Expandable Cage System1417-1207S2026-06-04
08809986491138BluEX Cervical Expandable Cage System1417-1307S2026-06-04
08809986491145CastleLoc-P Anterior Cervical Plate System6911-17152026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate System6911-17172026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate System6911-17192026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate System6911-17212026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate System6911-17232026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate System6911-17252026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02