FDA.reportPublic FDA data

EXULT Knee Replacement System

Primary DI
08800017262314
Brand
EXULT Knee Replacement System
Company
Corentec Co., Ltd
Model
K3.IAX.4572-16T
Device description
Tibial insert-Fixed-CR-XLPE-07-16T
Published
2020-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K192507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192507000LOSPA II Knee SystemCorentec Co., Ltd.2019-12-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017262314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017262314088000172623148800017262314

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017262178EXULT Knee Replacement SystemK3.IAX.4469-09T2020-01-10
08800017262185EXULT Knee Replacement SystemK3.IAX.4469-10T2020-01-10
08800017262192EXULT Knee Replacement SystemK3.IAX.4469-11T2020-01-10
08800017262208EXULT Knee Replacement SystemK3.IAX.4469-12T2020-01-10
08800017262215EXULT Knee Replacement SystemK3.IAX.4469-13T2020-01-10
08800017262222EXULT Knee Replacement SystemK3.IAX.4469-14T2020-01-10
08800017262239EXULT Knee Replacement SystemK3.IAX.4469-16T2020-01-10
08800017262246EXULT Knee Replacement SystemK3.IAX.4469-18T2020-01-10
08800017262253EXULT Knee Replacement SystemK3.IAX.4572-09T2020-01-10
08800017262260EXULT Knee Replacement SystemK3.IAX.4572-10T2020-01-10
08800017262277EXULT Knee Replacement SystemK3.IAX.4572-11T2020-01-10
08800017262284EXULT Knee Replacement SystemK3.IAX.4572-12T2020-01-10
08800017262291EXULT Knee Replacement SystemK3.IAX.4572-13T2020-01-10
08800017262307EXULT Knee Replacement SystemK3.IAX.4572-14T2020-01-10
08800017262321EXULT Knee Replacement SystemK3.IAX.4572-18T2020-01-10
08800017262338EXULT Knee Replacement SystemK3.IAX.4775-09T2020-01-10
08800017262345EXULT Knee Replacement SystemK3.IAX.4775-10T2020-01-10
08800017262352EXULT Knee Replacement SystemK3.IAX.4775-11T2020-01-10
08800017262369EXULT Knee Replacement SystemK3.IAX.4775-12T2020-01-10
08800017262376EXULT Knee Replacement SystemK3.IAX.4775-13T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262468EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10