World Knee PS TiN Femur Symmetric

GUDID 09348215105723

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis
Primary Device ID09348215105723
NIH Device Record Key1f3820f3-125a-46b4-aabd-e4288f5a349b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee PS TiN Femur Symmetric
Version Model Number121-20-4303
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
GS109348215105723 [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 Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [World Knee PS TiN Femur Symmetric]

09348215106089121-20-4903
09348215106027121-20-4803
09348215105969121-20-4703
09348215105907121-20-4603
09348215105846121-20-4503
09348215105785121-20-4403
09348215105723121-20-4303
09348215105662121-20-4203
09348215105600121-20-4103

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