FDA.reportPublic FDA data

PathLoc-L MIS Spinal System, LnK MIS Spinal System

Primary DI
08806344342507
Brand
PathLoc-L MIS Spinal System, LnK MIS Spinal System
Company
L&K BIOMED CO. ,LTD.
Model
2611-7550
Catalog number
2611-7550
Device description
MIS Screw – Open Type(Self-tapping, Double Thread) 7.5mmx50mm
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
08806344342507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344342507088063443425078806344342507

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
08809986482501CastleLoc Pectus Bar SystemPF12-28122026-09-22
08809986482518CastleLoc Pectus Bar SystemPF12-28152026-09-22
08809986482525CastleLoc Pectus Bar SystemPF12-28182026-09-22
08809986482532CastleLoc Pectus Bar SystemPF12-28222026-09-22
08809986482549CastleLoc Pectus Bar SystemPF12-30182026-09-22
08809986482556CastleLoc Pectus Bar SystemPFB12-20122026-09-22
08809986482563CastleLoc Pectus Bar SystemPFB12-20152026-09-22
08809986482570CastleLoc Pectus Bar SystemPFB12-20182026-09-22
08809986482587CastleLoc Pectus Bar SystemPFB12-20222026-09-22
08809986493620LnK Spinal Instrument SystemTA29-20062026-09-21
08809986493637LnK Spinal Instrument SystemTA29-20092026-09-21
08809986493644LnK Spinal Instrument SystemTA29-20122026-09-21
08809986493651LnK Spinal Instrument SystemTA29-20152026-09-21
08809986493668LnK Spinal Instrument SystemTA29-25062026-09-21
08809986493675LnK Spinal Instrument SystemTA29-25092026-09-21
08809986493682LnK Spinal Instrument SystemTA29-25122026-09-21
08809986493699LnK Spinal Instrument SystemTA29-25152026-09-21
08809986493705LnK Spinal Instrument SystemTA29-30062026-09-21
08809986493712LnK Spinal Instrument SystemTA29-30092026-09-21
08809986493729LnK Spinal Instrument SystemTA29-30122026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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