SignaSure Poly

GUDID 09348215083472

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215083472
• NIH Device Record Key: fc95c7d9-c021-4180-8209-16551574837b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Poly
• Version Model Number: 111-27-0205
• 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	09348215083472 [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 Poly]

• 09348215083472: 111-27-0205
• 09348215083465: 111-27-0204
• 09348215031404: 111-27-0259
• 09348215031398: 111-27-0257
• 09348215031381: 111-27-0255
• 09348215031374: 111-27-0253
• 09348215031367: 111-27-0251
• 09348215031350: 111-27-0249
• 09348215031343: 111-27-0247
• 09348215031312: 111-27-0243
• 09348215031299: 111-27-0239
• 09348215031282: 111-27-0237