World Knee UC All Poly Tibia

GUDID 09348215116194

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215116194
NIH Device Record Key1fb54dcb-d531-47df-847c-abd91f3c3ddf
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee UC All Poly Tibia
Version Model Number121-20-6438
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
GS109348215116194 [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 UC All Poly Tibia]

09348215116170121-20-6238
09348215116163121-20-6138
09348215116514121-20-6939
09348215116507121-20-6839
09348215116491121-20-6739
09348215116484121-20-6639
09348215116477121-20-6539
09348215116460121-20-6439
09348215116453121-20-6339
09348215116446121-20-6239
09348215116439121-20-6139
09348215116248121-20-6938
09348215116231121-20-6838
09348215116224121-20-6738
09348215116217121-20-6638
09348215116200121-20-6538
09348215116194121-20-6438
09348215116187121-20-6338

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