Femoral Trial

GUDID 09348215040970

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215040970
• NIH Device Record Key: 698bec86-1b5e-4f86-94d9-a7d5b23e7440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Trial
• Version Model Number: 122-10-0325
• 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	09348215040970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• HWT: Template
• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[09348215040970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-18
• Device Publish Date: 2018-10-02

On-Brand Devices [Femoral Trial]

• 09348215041014: 122-10-0329
• 09348215041007: 122-10-0328
• 09348215040994: 122-10-0327
• 09348215040987: 122-10-0326
• 09348215040970: 122-10-0325
• 09348215040963: 122-10-0324
• 09348215040956: 122-10-0323