Active-X Total Knee System

GUDID 09348215011260

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee femur prosthesis, metallic
Primary Device ID09348215011260
NIH Device Record Keyc8eb1f09-105a-4108-a993-d4d6bbc5e3f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameActive-X Total Knee System
Version Model Number10-1522-0367
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
GS109348215011260 [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 Date2016-09-22

On-Brand Devices [Active-X Total Knee System]

0934821501125310-1521-0347
0934821501124610-1522-0366
0934821501123910-1521-0346
0934821501122210-1522-0365
0934821501121510-1521-0345
0934821501120810-1522-0364
0934821501119210-1521-0344
0934821501118510-1522-0363
0934821501117810-1521-0343
0934821501116110-1522-0362
0934821501115410-1521-0342
0934821501096610-1513-0509
0934821501095910-1513-0508
0934821501094210-1513-0507
0934821501093510-1513-0506
0934821501092810-1513-0505
0934821501091110-1513-0504
0934821501090410-1513-0503
0934821501089810-1513-0502
0934821501088110-1513-0501
0934821501087410-1513-0500
0934821501132110-1522-0270
0934821501131410-1521-0250
0934821501130710-1522-0369
0934821501129110-1521-0349
0934821501128410-1522-0368
0934821501127710-1521-0348
0934821501126010-1522-0367
09348215018139121-13-0005
09348215018122121-13-0004
09348215018115121-13-0003
09348215018108121-13-0002
09348215018092121-13-0001
0934821501308010-1514-0754
0934821501307310-1514-0753
0934821501306610-1514-0752
0934821501305910-1514-0751
0934821501304210-1514-0750

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