Salto Talaris Flat Cut Total Ankle System

GUDID 00816847022736

A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

3D SYSTEMS, INC.

Osteotomy guide, single-use

• Primary Device ID: 00816847022736
• NIH Device Record Key: 45afa59f-f380-4094-afaf-62f13de7ff0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salto Talaris Flat Cut Total Ankle System
• Version Model Number: Tibia Cutting Guide
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00816847022736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243173

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

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

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

[00816847022736]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-10

On-Brand Devices [Salto Talaris Flat Cut Total Ankle System]

• 00816847022750: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and in
• 00816847022743: A physical guide that is composed of patient's bony anatomy and allows for precise location of p
• 00816847022736: A physical guide that is composed of patient's bony anatomy and allows for precise location of p