Trial Cage 20deg 18S

GUDID 09348215066697

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215066697
• NIH Device Record Key: 816f4be8-4916-45bb-8694-5fba625f6d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Cage 20deg 18S
• Version Model Number: 135-15-0138
• 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	09348215066697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163625

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

[09348215066697]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215039295 - Liner Impactor: 2026-02-09
• 09348215039301 - Liner Impactor: 2026-02-09
• 09348215039318 - Liner Impactor: 2026-02-09
• 09348215039325 - Liner Impactor: 2026-02-09
• 09348215039332 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039349 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039356 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039363 - Ceramic Liner Inserter Impactor Head: 2026-02-09