FDA.reportPublic FDA data

Exult Knee Replacement System

Primary DI
08809945887248
Brand
Exult Knee Replacement System
Company
Corentec Co., Ltd
Model
K3.IDX.3860-24T
Device description
EXULT Tibial insert-Fixed-UC-XLPE-03-24T
Published
2024-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K242046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242046000EXULT Knee Replacement SystemCorentec Co., Ltd.2024-08-01JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809945887248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809945887248088099458872488809945887248

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017271088BENCOXHA.02F.00012026-05-06
08800017261294EXULT Knee Replacement SystemK3.IAN.4266-09T2020-01-10
08800017261300EXULT Knee Replacement SystemK3.IAN.4266-10T2020-01-10
08800017261317EXULT Knee Replacement SystemK3.IAN.4266-11T2020-01-10
08800017261324EXULT Knee Replacement SystemK3.IAN.4266-12T2020-01-10
08800017261331EXULT Knee Replacement SystemK3.IAN.4266-13T2020-01-10
08800017261348EXULT Knee Replacement SystemK3.IAN.4266-14T2020-01-10
08800017261355EXULT Knee Replacement SystemK3.IAN.4266-16T2020-01-10
08800017261362EXULT Knee Replacement SystemK3.IAN.4266-18T2020-01-10
08800017261379EXULT Knee Replacement SystemK3.IAN.4469-09T2020-01-10
08800017261386EXULT Knee Replacement SystemK3.IAN.4469-10T2020-01-10
08800017261393EXULT Knee Replacement SystemK3.IAN.4469-11T2020-01-10
08800017261409EXULT Knee Replacement SystemK3.IAN.4469-12T2020-01-10
08800017261416EXULT Knee Replacement SystemK3.IAN.4469-13T2020-01-10
08800017261423EXULT Knee Replacement SystemK3.IAN.4469-14T2020-01-10
08800017261430EXULT Knee Replacement SystemK3.IAN.4469-16T2020-01-10
08800017261447EXULT Knee Replacement SystemK3.IAN.4469-18T2020-01-10
08800017261454EXULT Knee Replacement SystemK3.IAN.4572-09T2020-01-10
08800017261461EXULT Knee Replacement SystemK3.IAN.4572-10T2020-01-10
08800017261478EXULT Knee Replacement SystemK3.IAN.4572-11T2020-01-10

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Primary DI, Brand, Company table
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