World Knee CR All Poly Tibia

GUDID 09348215116026

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215116026
NIH Device Record Keyc888063c-7c7d-40a6-b74b-66e1e446fcaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee CR All Poly Tibia
Version Model Number121-20-6518
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
GS109348215116026 [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 Date2023-08-07
Device Publish Date2023-07-28

On-Brand Devices [World Knee CR All Poly Tibia]

09348215116255121-20-6119
09348215116330121-20-6919
09348215116323121-20-6819
09348215116316121-20-6719
09348215116309121-20-6619
09348215116293121-20-6519
09348215116286121-20-6419
09348215116279121-20-6319
09348215116262121-20-6219
09348215116064121-20-6918
09348215116057121-20-6818
09348215116040121-20-6718
09348215116033121-20-6618
09348215116026121-20-6518
09348215116019121-20-6418
09348215116002121-20-6318
09348215115999121-20-6128
09348215115982121-20-6118

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