Rx Knee All Poly Tibia Augment - Half - 8mm

GUDID 09348215110611

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215110611
NIH Device Record Key47a8e4a2-d765-4a1c-9299-9bfa30ef9b52
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee All Poly Tibia Augment - Half - 8mm
Version Model Number121-20-9202
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
GS109348215110611 [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 - Half - 8mm]

09348215111717121-20-9289
09348215111700121-20-9288
09348215111694121-20-9287
09348215111687121-20-9286
09348215111670121-20-9285
09348215111663121-20-9284
09348215111656121-20-9283
09348215111649121-20-9282
09348215111632121-20-9281
09348215110680121-20-9209
09348215110673121-20-9208
09348215110666121-20-9207
09348215110659121-20-9206
09348215110642121-20-9205
09348215110635121-20-9204
09348215110628121-20-9203
09348215110611121-20-9202
09348215110604121-20-9201

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