World Knee PS All Poly Tibia

GUDID 09348215116101

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215116101
NIH Device Record Key81a597a2-e87e-40f1-8a31-62646fcf184d
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee PS All Poly Tibia
Version Model Number121-20-6408
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
GS109348215116101 [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 PS All Poly Tibia]

09348215116422121-20-6909
09348215116415121-20-6809
09348215116408121-20-6709
09348215116392121-20-6609
09348215116385121-20-6509
09348215116378121-20-6409
09348215116125121-20-6608
09348215116095121-20-6308
09348215116361121-20-6309
09348215116354121-20-6209
09348215116347121-20-6109
09348215116156121-20-6908
09348215116149121-20-6808
09348215116132121-20-6708
09348215116118121-20-6508
09348215116101121-20-6408
09348215116088121-20-6208
09348215116071121-20-6108

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