Origin Trial Neck

GUDID 09348215039806

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215039806
• NIH Device Record Key: 302680e8-3bba-442b-99ec-5d43f3365cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Trial Neck
• Version Model Number: 111-182-021
• 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	09348215039806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• HWT: Template
• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

Moist Heat or Steam Sterilization

[09348215039806]

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 [Origin Trial Neck]

• 09348215039813: 111-182-022
• 09348215039806: 111-182-021
• 09348215039790: 111-182-020