World Knee System

GUDID 09348215037482

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215037482
NIH Device Record Key25a1477e-21db-4fea-950d-41aedc7c53ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee System
Version Model Number121-20-6836
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215037482 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2019-01-11

On-Brand Devices [World Knee System]

09348215053383121-20-8904
09348215053376121-20-8903
09348215053369121-20-8902
09348215053352121-20-8901
09348215046002121-20-4900
09348215045999121-20-4800
09348215045982121-20-4700
09348215045975121-20-4600
09348215045968121-20-4500
09348215045951121-20-4400
09348215045944121-20-4300
09348215045937121-20-4200
09348215045920121-20-4100
09348215037932121-20-0913
09348215037925121-20-0813
09348215037918121-20-0713
09348215037901121-20-0613
09348215037895121-20-0513
09348215037888121-20-0413
09348215037871121-20-0313
09348215037864121-20-0213
09348215037857121-20-0113
09348215037840121-20-0903
09348215037833121-20-0803
09348215037826121-20-0703
09348215037819121-20-0603
09348215037802121-20-0503
09348215037796121-20-0403
09348215037789121-20-0303
09348215037772121-20-0203
09348215037765121-20-0103
09348215037659121-20-9000
09348215037529121-20-6936
09348215037512121-20-6934
09348215037505121-20-6932
09348215037499121-20-6930
09348215037482121-20-6836
09348215037475121-20-6834
09348215037468121-20-6832
09348215037451121-20-6830
09348215037444121-20-6736
09348215037437121-20-6734
09348215037420121-20-6732
09348215037413121-20-6730
09348215037406121-20-6636
09348215037390121-20-6634
09348215037383121-20-6632
09348215037376121-20-6630
09348215037369121-20-6536
09348215037352121-20-6534

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