Kinos Total Ankle Instrumentation

GUDID 00840097515243

X-Blade, Right

Restor3d, Inc.

Surgical saw blade, reciprocating, reusable

• Primary Device ID: 00840097515243
• NIH Device Record Key: 42fcada5-627c-4955-9019-b2b9b5aeb350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Total Ankle Instrumentation
• Version Model Number: 5801-4072
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097515243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232595

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

[00840097515243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [Kinos Total Ankle Instrumentation]

• 00840097517742: Short X-Blade, Right
• 00840097517735: Short X-Blade, Left
• 00840097515243: X-Blade, Right
• 00840097515236: X-Blade, Left