FDA.reportPublic FDA data

L&K Biomed DLIF PEEK Cage

Primary DI
08806344304215
Brand
L&K Biomed DLIF PEEK Cage
Company
L&K BIOMED CO. ,LTD.
Model
3862-4015
Catalog number
3862-4015
Device description
L&K Biomed DLIF PEEK Cage 22 x 40 12 15mm 1EA, LLIF PEEK Cage, 12︒,22x40x15mm
Published
2015-11-16
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
08806344304215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344304215088063443042158806344304215

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
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
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03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
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