FDA.reportPublic FDA data

EXULT Knee Replacement System

Primary DI
08800017264868
Brand
EXULT Knee Replacement System
Company
Corentec Co., Ltd
Model
K3.IBN.3657-22T
Device description
EXULT Tibial insert-Fixed-PS-02-22T
Published
2020-01-10
Public version status
Update
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
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
08800017264868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017264868088000172648688800017264868

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82414107176sungwon.yang@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
08809945895311EXULT Special Instrument(CM)KZ.026.Z0032026-10-15
08809945895328EXULT Special Instrument(CM)KZ.026.Z0122026-10-15
08809945895335EXULT Special Instrument(CM)KZ.026.Z0112026-10-15
08809945895342EXULT Special Instrument(CM)KZ.026.Z0102026-10-15
08809945895359EXULT Special Instrument(CM)KZ.026.Z0092026-10-15
08809945895366EXULT Special Instrument(CM)KZ.026.Z0082026-10-15
08809945895373EXULT Special Instrument(CM)KZ.026.Z0072026-10-15
08809945895380EXULT Special Instrument(CM)KZ.026.Z0062026-10-15
08809945895397EXULT Special Instrument(CM)KZ.026.Z0052026-10-15
08809945895403EXULT Special Instrument(CM)KZ.026.Z0042026-10-15
08800068958112BENCOX THR SystemHA.0C3.02842021-07-20
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01
08806373897351BENCOXHA.018.32392026-07-01
08806373897368BENCOXHA.018.36442026-07-01
08806373897375BENCOXHA.018.36482026-07-01
08806373897382BENCOXHA.018.36522026-07-01
08809945870332BENCOX InstrumentHA.014.00042024-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809945895311EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895328EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895335EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895342EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895359EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895366EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895373EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895380EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895397EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895403EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08906067247247Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247254Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247261Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247278Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247285Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247308Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247315Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247353Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247377Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247384Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05