Tibial Trial PS Insert

GUDID 09348215042004

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215042004
• NIH Device Record Key: 024597e1-fc9a-4a31-aee8-53cb3f45804d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial Trial PS Insert
• Version Model Number: 122-10-0443
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	09348215042004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• HWT: Template

Sterilization

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

[09348215042004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-13
• Device Publish Date: 2018-10-05

On-Brand Devices [Tibial Trial PS Insert]

• 09348215042011: 122-10-0557
• 09348215042004: 122-10-0443
• 09348215041991: 122-10-0442
• 09348215041984: 122-10-0441
• 09348215041977: 122-10-0440
• 09348215041960: 122-10-0439
• 09348215041953: 122-10-0438
• 09348215041946: 122-10-0437