FDA.reportPublic FDA data

L&K Biomed DLIF PEEK Cage

Primary DI
08806344303720
Brand
L&K Biomed DLIF PEEK Cage
Company
L&K BIOMED CO. ,LTD.
Model
3860-4511
Catalog number
3860-4511
Device description
L&K Biomed DLIF PEEK Cage 22 x 45 10 11mm 1EA, LLIF PEEK Cage, 10︒,22x45x11mm
Published
2015-11-16
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
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344303720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344303720088063443037208806344303720

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
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
Primary DIBrandCompanyProduct codePublished
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045670XIA IStryker CorporationKWQ2014-12-08
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationKWQ2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08