Cemented Origin Stem

GUDID 09348215054649

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 09348215054649
• NIH Device Record Key: 81c8e324-e83e-4176-bb26-7b1926e6deea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cemented Origin Stem
• Version Model Number: 111-42-1602
• 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	09348215054649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201951

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 2020-08-17
• Device Publish Date: 2020-08-07

On-Brand Devices [Cemented Origin Stem]

• 09348215054755: 111-42-1803
• 09348215054748: 111-42-1603
• 09348215054731: 111-42-1503
• 09348215054724: 111-42-1403
• 09348215054717: 111-42-1303
• 09348215054700: 111-42-1203
• 09348215054694: 111-42-1103
• 09348215054687: 111-42-1003
• 09348215054670: 111-42-0903
• 09348215054663: 111-42-0803
• 09348215054656: 111-42-1802
• 09348215054649: 111-42-1602
• 09348215054632: 111-42-1502
• 09348215054625: 111-42-1402
• 09348215054618: 111-42-1302
• 09348215054601: 111-42-1202
• 09348215054595: 111-42-1102
• 09348215054588: 111-42-1002
• 09348215054571: 111-42-0902
• 09348215054564: 111-42-0802