FDA.reportPublic FDA data

CentLoc Total Knee System

Primary DI
08800036804410
Brand
CentLoc Total Knee System
Company
RootLoc Co., Ltd.
Model
7132-1709
Catalog number
7132-1709
Device description
CentLoc Tibial insert component CR type Size10 9mm
Published
2019-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182370000Acculoc Total Knee SystemRootloc Co., Ltd.2018-09-27JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800036804410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800036804410088000368044108800036804410

GMDN Terms#

Term, Definition table
TermDefinition
Femur/tibia shaft prosthesisA sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve femoral/tibial extension, knee femur prosthesis, or body femoral/tibial extension stem; it is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694670830
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800036803215CentLoc Total Knee System7132-05097132-05092019-09-25
08800036803222CentLoc Total Knee System7132-05107132-05102019-09-25
08800036803239CentLoc Total Knee System7132-05117132-05112019-09-25
08800036803246CentLoc Total Knee System7132-05127132-05122019-09-25
08800036803253CentLoc Total Knee System7132-05137132-05132019-09-25
08800036803260CentLoc Total Knee System7132-05147132-05142019-09-25
08800036803277CentLoc Total Knee System7132-05157132-05152019-09-25
08800036803284CentLoc Total Knee System7132-05167132-05162019-09-25
08800036803291CentLoc Total Knee System7132-05177132-05172019-09-25
08800036803307CentLoc Total Knee System7132-05187132-05182019-09-25
08800036803314CentLoc Total Knee System7132-06097132-06092019-09-25
08800036803321CentLoc Total Knee System7132-06107132-06102019-09-25
08800036803338CentLoc Total Knee System7132-06117132-06112019-09-25
08800036803345CentLoc Total Knee System7132-06127132-06122019-09-25
08800036803352CentLoc Total Knee System7132-06137132-06132019-09-25
08800036803369CentLoc Total Knee System7132-06147132-06142019-09-25
08800036803376CentLoc Total Knee System7132-06157132-06152019-09-25
08800036803383CentLoc Total Knee System7132-06167132-06162019-09-25
08800036803390CentLoc Total Knee System7132-06177132-06172019-09-25
08800036803406CentLoc Total Knee System7132-06187132-06182019-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24