Rx Knee All Poly Tibia Augment - Third

GUDID 09348215123888

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215123888
NIH Device Record Keyd347c21d-b6ad-43ac-b1d5-ec429a245835
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee All Poly Tibia Augment - Third
Version Model Number121-20-9338
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
GS109348215123888 [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 - Third]

09348215123987121-20-9329
09348215123970121-20-9328
09348215123963121-20-9327
09348215123956121-20-9326
09348215123949121-20-9325
09348215123932121-20-9324
09348215123925121-20-9323
09348215123918121-20-9322
09348215123901121-20-9321
09348215123895121-20-9339
09348215123888121-20-9338
09348215123871121-20-9337
09348215123864121-20-9336
09348215123857121-20-9335
09348215123840121-20-9334
09348215123833121-20-9333
09348215123826121-20-9332
09348215123819121-20-9331

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