SignaSure Cemented Cup

GUDID 09348215031176

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215031176
• NIH Device Record Key: 5674b6a9-39e1-4c42-a1ef-8b83b4fad63d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Cemented Cup
• Version Model Number: 111-27-0652
• 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	09348215031176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211742

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: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [SignaSure Cemented Cup]

• 09348215031237: 111-27-0664
• 09348215031220: 111-27-0662
• 09348215031213: 111-27-0660
• 09348215031206: 111-27-0658
• 09348215031190: 111-27-0656
• 09348215031183: 111-27-0654
• 09348215031176: 111-27-0652
• 09348215031169: 111-27-0650
• 09348215031152: 111-27-0648
• 09348215031145: 111-27-0646
• 09348215031138: 111-27-0644
• 09348215031121: 111-27-0642