World 10° Hooded Liner Size 32B

GUDID 09348215065300

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215065300
• NIH Device Record Key: bfeab779-ee8a-47b9-b4a4-d6dde3638a0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World 10° Hooded Liner Size 32B
• Version Model Number: 111-49-2150
• 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	09348215065300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201278

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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: 2021-03-15
• Device Publish Date: 2021-03-07

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215068608 - Marker Pin Inserter: 2024-09-11
• 09348215068646 - Cap Inserter: 2024-09-11
• 09348215068677 - Screw Inserter: 2024-09-11
• 09348215069209 - T-Bar Screw Inserter: 2024-09-11
• 09348215129224 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129231 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129248 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129255 - Verteloc Lumbar Cage: 2024-03-20