restor3d Kinos Axiom PSR

GUDID 00840097508948

Axiom Talar PSR

Restor3d

Osteotomy guide, single-use

• Primary Device ID: 00840097508948
• NIH Device Record Key: 1c889a6d-7dfe-4f46-9be7-a3a428b44dea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Kinos Axiom PSR
• Version Model Number: 5831-9003
• Company DUNS: 080819836
• Company Name: Restor3d
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097508948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223326

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

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

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

[00840097508948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [restor3d Kinos Axiom PSR ]

• 00840097508955: Axiom PSR Bone Model
• 00840097508948: Axiom Talar PSR
• 00840097508931: Axiom Tibial PSR, Right
• 00840097508924: Axiom Tibial PSR, Left
• 00840097509945: Axiom coupled PSR, Flat-cut
• 00840097509938: Kinos Axiom Coupled PSR, Chamfer-cut
• 00840097509921: Axiom Talar PSR, Flat Cut
• 00840097509914: Axiom Talar PSR Chamfer-Cut