Ossera™ AFX

GUDID 00840097532196

Ossera™ AFX, Rectangle, 52x34x74

Restor3d, Inc.

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840097532196
• NIH Device Record Key: 25779936-a440-4af9-8f6a-0aa4412466e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ossera™ AFX
• Version Model Number: 1744-5274-N
• Company DUNS: 080819836
• Company Name: Restor3d, 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: 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	00840097532196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242356

FDA Product Code

• SAI: Ankle Fusion Cage

Sterilization

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

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

[00840097532196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by Restor3d, Inc.

• 00840097513256 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Inserter
• 00840097513263 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Flat Cut Guide
• 00840097513270 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Distractor
• 00840097513287 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 26H
• 00840097515724 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 36H
• 00840097515731 - Ossera™ AFX Instrumentation: 2025-12-26 Ossera AFX™ Trial, Cylinder, 34D x 40H
• 00840097519333 - Ossera™ AFX: 2025-12-26 Ossera™ AFX, Cylinder, 34x26
• 00840097519340 - Ossera™ AFX: 2025-12-26 Ossera™ AFX, Cylinder, 34x36