TriVerse Asymmetric Patella

GUDID 09348215129538

SIGNATURE ORTHOPAEDICS PTY LTD

Polyethylene patella prosthesis
Primary Device ID09348215129538
NIH Device Record Key1244889c-bfe0-43a1-abf6-8d7244c647d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriVerse Asymmetric Patella
Version Model Number121-27-4110
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
GS109348215129538 [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 Date2025-02-19
Device Publish Date2025-02-11

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215129538 - TriVerse Asymmetric Patella2025-02-19
09348215129538 - TriVerse Asymmetric Patella2025-02-19
09348215092832 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092849 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092856 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092863 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092870 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092887 - Origin Complete Lateral Offset Collarless Cementless2025-01-01
09348215092894 - Origin Complete Lateral Offset Collarless Cementless2025-01-01

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