Aria Hip Stem

GUDID 09348215052652

SIGNATURE ORTHOPAEDICS PTY LTD

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• Primary Device ID: 09348215052652
• NIH Device Record Key: 0e5c8d5c-c071-4f4c-9f43-51fc42fe6d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aria Hip Stem
• Version Model Number: D111-20-6000
• 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	09348215052652 [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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Aria Hip Stem]

• 09348215052904: D111-20-6112
• 09348215052898: D111-20-6111
• 09348215052881: D111-20-6110
• 09348215052874: D111-20-6109
• 09348215052867: D111-20-6108
• 09348215052850: D111-20-6107
• 09348215052843: D111-20-6106
• 09348215052836: D111-20-6105
• 09348215052829: D111-20-6104
• 09348215052812: D111-20-6103
• 09348215052805: D111-20-6102
• 09348215052799: D111-20-6101
• 09348215052782: D111-20-6100
• 09348215052775: D111-20-6012
• 09348215052768: D111-20-6011
• 09348215052751: D111-20-6010
• 09348215052744: D111-20-6009
• 09348215052737: D111-20-6008
• 09348215052720: D111-20-6007
• 09348215052713: D111-20-6006
• 09348215052706: D111-20-6005
• 09348215052690: D111-20-6004
• 09348215052683: D111-20-6003
• 09348215052676: D111-20-6002
• 09348215052669: D111-20-6001
• 09348215052652: D111-20-6000