Rx Knee All Poly Tibia Augment - Half - 4mm

GUDID 09348215111557

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215111557
NIH Device Record Keycda3649a-45ab-49a0-8773-ed6d0996920e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee All Poly Tibia Augment - Half - 4mm
Version Model Number121-20-9272
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
GS109348215111557 [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 - 4mm]

09348215111625121-20-9279
09348215111618121-20-9278
09348215111601121-20-9277
09348215111595121-20-9276
09348215111588121-20-9275
09348215111571121-20-9274
09348215111564121-20-9273
09348215111557121-20-9272
09348215111540121-20-9271
09348215110598121-20-9199
09348215110581121-20-9198
09348215110574121-20-9197
09348215110567121-20-9196
09348215110550121-20-9195
09348215110543121-20-9194
09348215110536121-20-9193
09348215110529121-20-9192
09348215110512121-20-9191

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