Rx Knee All Poly Tibia Augment - Full - 8mm

GUDID 09348215110413

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215110413
NIH Device Record Key5660c116-1775-4f60-9148-9ab8c0b02fad
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee All Poly Tibia Augment - Full - 8mm
Version Model Number121-20-9179
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
GS109348215110413 [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 Date2024-11-20
Device Publish Date2024-11-12

On-Brand Devices [Rx Knee All Poly Tibia Augment - Full - 8mm]

09348215111441121-20-9259
09348215111434121-20-9258
09348215111427121-20-9257
09348215111410121-20-9256
09348215111403121-20-9255
09348215111397121-20-9254
09348215111380121-20-9253
09348215111373121-20-9252
09348215111366121-20-9251
09348215110413121-20-9179
09348215110406121-20-9178
09348215110390121-20-9177
09348215110383121-20-9176
09348215110376121-20-9175
09348215110369121-20-9174
09348215110352121-20-9173
09348215110345121-20-9172
09348215110338121-20-9171

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