FDA.reportPublic FDA data

EXULT Knee Replacement System

Primary DI
08800017265292
Brand
EXULT Knee Replacement System
Company
Corentec Co., Ltd
Model
K3.IBX.4469-24T
Device description
EXULT Tibial insert-Fixed-PS-XLPE-06-24T
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
08800017265292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017265292088000172652928800017265292

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
08800017271095BENCOXHA.02G.00012026-04-10
08800017269726EXULT Knee Replacement SystemK3.FAL.73762020-05-21
08800017269733EXULT Knee Replacement SystemK3.FAR.73762020-05-21
08800017269740EXULT Knee Replacement SystemK3.FAL.76782020-05-21
08800017269757EXULT Knee Replacement SystemK3.FAR.76782020-05-21
08800017269764EXULT Knee Replacement SystemK3.FBL.73762020-05-21
08800017269771EXULT Knee Replacement SystemK3.FBR.73762020-05-21
08800017269788EXULT Knee Replacement SystemK3.FBL.76782020-05-21
08800017269795EXULT Knee Replacement SystemK3.FBR.76782020-05-21
08800017260853EXULT Knee Replacement SystemK3.BFN.36572020-01-10
08800017260860EXULT Knee Replacement SystemK3.BFN.38602020-01-10
08800017260877EXULT Knee Replacement SystemK3.BFN.40632020-01-10
08800017260884EXULT Knee Replacement SystemK3.BFN.42662020-01-10
08800017260891EXULT Knee Replacement SystemK3.BFN.44692020-01-10
08800017260907EXULT Knee Replacement SystemK3.BFN.45722020-01-10
08800017260914EXULT Knee Replacement SystemK3.BFN.47752020-01-10
08800017260921EXULT Knee Replacement SystemK3.BFN.50792020-01-10
08800017260938EXULT Knee Replacement SystemK3.BFN.53832020-01-10
08800017260945EXULT Knee Replacement SystemK3.BFN.57862020-01-10
08800017260952EXULT Knee Replacement SystemK3.BFU.36572020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017269726EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269733EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269740EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269757EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269764EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269771EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269788EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269795EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10