restor3d Total Talus Replacement

GUDID 00840097509815

Total Talus, With Suture Hole, 100%

Restor3d, Inc.

Custom-made hand/foot bone prosthesis

• Primary Device ID: 00840097509815
• NIH Device Record Key: 4b9f9f4b-9c87-4b59-a3df-328dc27dbbbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Total Talus Replacement
• Version Model Number: 1102-13
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00840097509815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H230003

FDA Product Code

• QYQ: Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal

Sterilization

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

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

[00840097509815]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [restor3d Total Talus Replacement]

• 00840097509907: Impactor, Contoured
• 00840097509891: Impactor, Flat
• 00840097509884: Trial, Total Talus, 110%
• 00840097509877: Trial, Total Talus, 105%
• 00840097509860: Trial, Total Talus, 100%
• 00840097509853: Trial, Total Talus, 95%
• 00840097509846: Trial, Total Talus, 90%
• 00840097509839: Total Talus, With Suture Hole, 110%
• 00840097509822: Total Talus, With Suture Hole, 105%
• 00840097509815: Total Talus, With Suture Hole, 100%
• 00840097509808: Total Talus, With Suture Hole, 95%
• 00840097509792: Total Talus, With Suture Hole, 90%
• 00840097509785: Total Talus, No Suture Hole, 110%
• 00840097509778: Total Talus, No Suture Hole, 105%
• 00840097509761: Total Talus, No Suture Hole, 100%
• 00840097509754: Total Talus, No Suture Hole, 95%
• 00840097509747: Total Talus, No Suture Hole, 90%