World Knee Tibial Monotrial - CR

GUDID 09348215081232

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 09348215081232
• NIH Device Record Key: fa44698b-b6cc-41c6-ab4b-e5566f04a978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Tibial Monotrial - CR
• Version Model Number: 122-18-0592
• 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	09348215081232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181530

FDA Product Code

• HWT: Template

Sterilization

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

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

[09348215081232]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215129224 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129231 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129248 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129255 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129262 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129279 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129286 - Verteloc Lumbar Cage: 2024-03-20
• 09348215129293 - Verteloc Lumbar Cage: 2024-03-20