Cemented TSI Stem System

GUDID 09348215054502

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 09348215054502
• NIH Device Record Key: e81bdf6a-ffc1-4156-886d-8af048463505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cemented TSI Stem System
• Version Model Number: 111-34-1101
• 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	09348215054502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192024

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-17
• Device Publish Date: 2020-08-07

On-Brand Devices [Cemented TSI Stem System]

• 09348215054557: 111-34-1106
• 09348215054540: 111-34-1105
• 09348215054533: 111-34-1104
• 09348215054526: 111-34-1103
• 09348215054519: 111-34-1102
• 09348215054502: 111-34-1101