FDA.reportPublic FDA data

PathLoc-L MIS Spinal System, LnK MIS Spinal System

Primary DI
08806344342484
Brand
PathLoc-L MIS Spinal System, LnK MIS Spinal System
Company
L&K BIOMED CO. ,LTD.
Model
1306-0000
Catalog number
1306-0000
Device description
Set Screw Star Type (Closed Type with Rescue Hole)
Published
2017-04-04
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161766000PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.2016-08-22NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344342484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344342484088063443424848806344342484

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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
08809986490001CastleLoc Pectus Bar SystemPB28-01752026-05-27
08809986490018CastleLoc Pectus Bar SystemPB28-01802026-05-27
08809986490025CastleLoc Pectus Bar SystemPB28-01852026-05-27
08809986490032CastleLoc Pectus Bar SystemPB28-01902026-05-27
08809986490049CastleLoc Pectus Bar SystemPB28-01952026-05-27
08809986490056CastleLoc Pectus Bar SystemPB28-02002026-05-27
08809986490063CastleLoc Pectus Bar SystemPB30-01752026-05-27
08809986490087CastleLoc Pectus Bar SystemPB30-01852026-05-27
08809986490094CastleLoc Pectus Bar SystemPB30-01902026-05-27
08809986490100CastleLoc Pectus Bar SystemPB30-01952026-05-27
08809986490117CastleLoc Pectus Bar SystemPB30-02002026-05-27
08809986490124CastleLoc Pectus Bar SystemPB28-11752026-05-27
08809986490131CastleLoc Pectus Bar SystemPB28-11802026-05-27
08809986490148CastleLoc Pectus Bar SystemPB28-11852026-05-27
08809986490155CastleLoc Pectus Bar SystemPB28-11902026-05-27
08809986490162CastleLoc Pectus Bar SystemPB28-11952026-05-27
08809986490179CastleLoc Pectus Bar SystemPB28-12002026-05-27
08809986490186CastleLoc Pectus Bar SystemPB30-11752026-05-27
08809986490193CastleLoc Pectus Bar SystemPB30-11802026-05-27
08809986490209CastleLoc Pectus Bar SystemPB30-11852026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28