EXULT Knee Replacement System

GUDID 08800017261874

Tibial insert-Fixed-CR-XLPE-02-11T

Corentec Co., Ltd

Knee tibia prosthesis trial
Primary Device ID08800017261874
NIH Device Record Key231ef03e-f34f-4f01-9210-74281517ca0f
Commercial Distribution Discontinuation2020-01-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEXULT Knee Replacement System
Version Model NumberK3.IAX.3657-11T
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com
Phone+82414107176
Emailsungwon.yang@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017261874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-17
Device Publish Date2020-01-09

On-Brand Devices [EXULT Knee Replacement System]

08800017294872Tibial Insert Trial CR #08 T18
08800017294865Tibial Insert Trial CR #08 T16
08800017294858Tibial Insert Trial CR #08 T14
08800017294841Tibial Insert Trial CR #08 T13
08800017294834Tibial Insert Trial CR #08 T12
08800017294827Tibial Insert Trial CR #08 T11
08800017294810Tibial Insert Trial CR #08 T10
08800017294803Tibial Insert Trial CR #08 T09
08800017294797Tibial Insert Trial CR #07 T24
08800017294780Tibial Insert Trial CR #07 T22
08800017294773Tibial Insert Trial CR #07 T20
08800017294766Tibial Insert Trial CR #07 T18
08800017294759Tibial Insert Trial CR #07 T16
08800017294742Tibial Insert Trial CR #07 T14
08800017294735Tibial Insert Trial CR #07 T13
08800017294728Tibial Insert Trial CR #07 T12
08800017294711Tibial Insert Trial CR #07 T11
08800017294704Tibial Insert Trial CR #07 T10
08800017294698Tibial Insert Trial CR #07 T09
08800017294681Tibial Insert Trial CR #06 T24
08800017294674Tibial Insert Trial CR #06 T22
08800017294667Tibial Insert Trial CR #06 T20
08800017294650Tibial Insert Trial CR #06 T18
08800017294643Tibial Insert Trial CR #06 T16
08800017294636Tibial Insert Trial CR #06 T14
08800017294629Tibial Insert Trial CR #06 T13
08800017294612Tibial Insert Trial CR #06 T12
08800017294605Tibial Insert Trial CR #06 T11
08800017294599Tibial Insert Trial CR #06 T10
08800017294582Tibial Insert Trial CR #06 T09
08800017294575Tibial Insert Trial CR #05 T24
08800017294568Tibial Insert Trial CR #05 T22
08800017294551Tibial Insert Trial CR #05 T20
08800017294544Tibial Insert Trial CR #05 T18
08800017294537Tibial Insert Trial CR #05 T16
08800017294520Tibial Insert Trial CR #05 T14
08800017294513Tibial Insert Trial CR #05 T13
08800017294506Tibial Insert Trial CR #05 T12
08800017294490Tibial Insert Trial CR #05 T11
08800017294483Tibial Insert Trial CR #05 T10
08800017294476Tibial Insert Trial CR #05 T09
08800017294469Tibial Insert Trial CR #04 T24
08800017294452Tibial Insert Trial CR #04 T22
08800017294445Tibial Insert Trial CR #04 T20
08800017294438Tibial Insert Trial CR #04 T18
08800017294421Tibial Insert Trial CR #04 T16
08800017294414Tibial Insert Trial CR #04 T14
08800017294407Tibial Insert Trial CR #04 T13
08800017294391Tibial Insert Trial CR #04 T12
08800017294384Tibial Insert Trial CR #04 T11

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