Nebula High Offset Size 3

GUDID 09348215134679

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215134679
• NIH Device Record Key: 8d266100-2f45-454c-8cf9-417ad021b6a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebula High Offset Size 3
• Version Model Number: 111-59-0103
• 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	09348215134679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243029

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: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215039295 - Liner Impactor: 2026-02-09
• 09348215039301 - Liner Impactor: 2026-02-09
• 09348215039318 - Liner Impactor: 2026-02-09
• 09348215039325 - Liner Impactor: 2026-02-09
• 09348215039332 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039349 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039356 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039363 - Ceramic Liner Inserter Impactor Head: 2026-02-09