Ossera™ AFX

GUDID 00840097532103

Ossera™ AFX, Rectangle, 52x34x56

Restor3d, Inc.

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840097532103
• NIH Device Record Key: cbf43170-f8c4-4650-b44d-29d0b12fcb1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ossera™ AFX
• Version Model Number: 1744-5256-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	00840097532103 [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

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

Moist Heat or Steam Sterilization

[00840097532103]

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

On-Brand Devices [ Ossera™ AFX]

• 00840097532127: Ossera™ AFX, Rectangle, 52x34x60
• 00840097532103: Ossera™ AFX, Rectangle, 52x34x56
• 00840097532011: Ossera™ AFX, Rectangle, 52x34x14
• 00840097531977: Ossera™ AFX, Rectangle, 48x34x68