Active-X Total Knee System

GUDID 09348215010942

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 09348215010942
• NIH Device Record Key: c9125e3f-98be-4624-b72f-9f7248a62c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active-X Total Knee System
• Version Model Number: 10-1513-0507
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215010942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160159

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-22

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

• 09348215011253: 10-1521-0347
• 09348215011246: 10-1522-0366
• 09348215011239: 10-1521-0346
• 09348215011222: 10-1522-0365
• 09348215011215: 10-1521-0345
• 09348215011208: 10-1522-0364
• 09348215011192: 10-1521-0344
• 09348215011185: 10-1522-0363
• 09348215011178: 10-1521-0343
• 09348215011161: 10-1522-0362
• 09348215011154: 10-1521-0342
• 09348215010966: 10-1513-0509
• 09348215010959: 10-1513-0508
• 09348215010942: 10-1513-0507
• 09348215010935: 10-1513-0506
• 09348215010928: 10-1513-0505
• 09348215010911: 10-1513-0504
• 09348215010904: 10-1513-0503
• 09348215010898: 10-1513-0502
• 09348215010881: 10-1513-0501
• 09348215010874: 10-1513-0500
• 09348215011321: 10-1522-0270
• 09348215011314: 10-1521-0250
• 09348215011307: 10-1522-0369
• 09348215011291: 10-1521-0349
• 09348215011284: 10-1522-0368
• 09348215011277: 10-1521-0348
• 09348215011260: 10-1522-0367
• 09348215018139: 121-13-0005
• 09348215018122: 121-13-0004
• 09348215018115: 121-13-0003
• 09348215018108: 121-13-0002
• 09348215018092: 121-13-0001
• 09348215013080: 10-1514-0754
• 09348215013073: 10-1514-0753
• 09348215013066: 10-1514-0752
• 09348215013059: 10-1514-0751
• 09348215013042: 10-1514-0750