FDA.reportPublic FDA data

CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System

Primary DI
08806344331099
Brand
CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1531-75105
Catalog number
1531-75105
Device description
Reduction Mono Axial Screw(Non-Self Tapping) Ø7.5, 105mm
Published
2016-12-14
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162801000CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.2016-11-03MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344331099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344331099088063443310998806344331099

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
08809986482600CastleLoc Pectus Bar SystemPFB12-23152026-10-26
08809986482617CastleLoc Pectus Bar SystemPFB12-23182026-10-26
08809986482624CastleLoc Pectus Bar SystemPFB12-23222026-10-26
08809986482631CastleLoc Pectus Bar SystemPFB12-25182026-10-26
08809986482648CastleLoc Pectus Bar SystemPFB12-28122026-10-26
08809986482655CastleLoc Pectus Bar SystemPFB12-28152026-10-26
08809986482662CastleLoc Pectus Bar SystemPFB12-28182026-10-26
08809986482679CastleLoc Pectus Bar SystemPFB12-28222026-10-26
08809986482686CastleLoc Pectus Bar SystemPFB12-30182026-10-26
08809986482792CastleLoc Pectus Bar SystemOB28-01002026-10-26
08809986482808CastleLoc Pectus Bar SystemOB28-01052026-10-26
08809986482877CastleLoc Pectus Bar SystemOB28-01402026-10-26
08809986482884CastleLoc Pectus Bar SystemOB28-01452026-10-26
08809986482891CastleLoc Pectus Bar SystemOB28-01502026-10-26
08809986482907CastleLoc Pectus Bar SystemOB28-01552026-10-26
08809986482914CastleLoc Pectus Bar SystemOB28-01602026-10-26
08809986482921CastleLoc Pectus Bar SystemOB28-01652026-10-26
08809986482938CastleLoc Pectus Bar SystemOB28-01702026-10-26
08809986482945CastleLoc Pectus Bar SystemOB28-01752026-10-26
08809986482952CastleLoc Pectus Bar SystemOB28-01802026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNH2026-10-18
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNH2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNI2026-10-18
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07300251Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNH2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.MNI2026-10-14