Logical High Wall Liner

GUDID 09348215124496

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215124496
• NIH Device Record Key: 40243978-2486-450d-8327-54b948d260d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical High Wall Liner
• Version Model Number: 111-12-1250
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215124496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [Logical High Wall Liner ]

• 09348215124571: 111-12-1460
• 09348215124564: 111-12-1456
• 09348215124557: 111-12-1660
• 09348215124540: 111-12-1656
• 09348215124533: 111-12-1652
• 09348215124526: 111-12-1260
• 09348215124519: 111-12-1256
• 09348215124502: 111-12-1252
• 09348215124496: 111-12-1250
• 09348215124489: 111-12-1852
• 09348215124472: 111-12-1850
• 09348215124465: 111-12-1844