Evolve

GUDID 09348215002510

SIGNATURE ORTHOPAEDICS PTY LTD

Metallic femoral head prosthesis

• Primary Device ID: 09348215002510
• NIH Device Record Key: 747efad9-26c0-40e4-b0fc-ff40d922b533
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve
• Version Model Number: 111-25-0046
• 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	09348215002510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143184

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-09-28

On-Brand Devices [Evolve]

• 09348215002657: 111-25-0060
• 09348215002640: 111-25-0059
• 09348215002633: 111-25-0058
• 09348215002626: 111-25-0057
• 09348215002619: 111-25-0056
• 09348215002602: 111-25-0055
• 09348215002596: 111-25-0054
• 09348215002589: 111-25-0053
• 09348215002572: 111-25-0052
• 09348215002565: 111-25-0051
• 09348215002558: 111-25-0050
• 09348215002541: 111-25-0049
• 09348215002534: 111-25-0048
• 09348215002527: 111-25-0047
• 09348215002510: 111-25-0046
• 09348215002503: 111-25-0045
• 09348215002497: 111-25-0044
• 09348215002480: 111-25-0043
• 09348215002473: 111-25-0042
• 09348215002466: 111-25-0041
• 09348215002459: 111-25-0040