Genius Total Knee System

GUDID 09348215021160

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee femur prosthesis, metallic
Primary Device ID09348215021160
NIH Device Record Key58f3e989-60e9-4143-bb54-776c540f97b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius Total Knee System
Version Model Number121-07-1066
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
GS109348215021160 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2018-01-26

On-Brand Devices [Genius Total Knee System]

09348215021566121-07-1166
09348215021559121-07-1165
09348215021542121-07-1164
09348215021535121-07-1163
09348215021528121-07-1162
09348215021511121-07-1161
09348215021504121-07-1160
09348215021498121-07-1106
09348215021481121-07-1105
09348215021474121-07-1104
09348215021467121-07-1103
09348215021450121-07-1102
09348215021443121-07-1101
09348215021436121-07-1100
09348215021429121-07-8066
09348215021412121-07-8065
09348215021405121-07-8064
09348215021399121-07-8063
09348215021382121-07-8062
09348215021375121-07-8061
09348215021368121-07-8060
09348215021351121-07-8006
09348215021344121-07-8005
09348215021337121-07-8004
09348215021320121-07-8003
09348215021313121-07-8002
09348215021306121-07-8001
09348215021290121-07-8000
09348215021283121-07-5066
09348215021276121-07-5065
09348215021269121-07-5064
09348215021252121-07-5063
09348215021245121-07-5062
09348215021238121-07-5061
09348215021221121-07-5006
09348215021214121-07-5005
09348215021207121-07-5004
09348215021191121-07-5003
09348215021184121-07-5002
09348215021177121-07-5001
09348215021160121-07-1066
09348215021153121-07-1065
09348215021146121-07-1064
09348215021139121-07-1063
09348215021122121-07-1062
09348215021115121-07-1061
09348215021108121-07-1060
09348215021092121-07-1006
09348215021085121-07-1005
09348215021078121-07-1004

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.