SignaSure Cementless Cup

GUDID 09348215031107

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215031107
• NIH Device Record Key: dbb7cd0a-585a-4b70-be24-57ad5d4ddf4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Cementless Cup
• Version Model Number: 111-27-0162
• 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	09348215031107 [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 Cementless Cup]

• 09348215031114: 111-27-0164
• 09348215031107: 111-27-0162
• 09348215031091: 111-27-0160
• 09348215031084: 111-27-0158
• 09348215031077: 111-27-0156
• 09348215031060: 111-27-0154
• 09348215031053: 111-27-0152
• 09348215031046: 111-27-0150
• 09348215031039: 111-27-0148
• 09348215031022: 111-27-0146
• 09348215031015: 111-27-0144
• 09348215031008: 111-27-0142