Ossera™ AFX Instrumentation

GUDID 00840097524450

Ossera™ AFX Trial, Pill, 46x60

Restor3d, Inc.

Surgical implant template, single-use

• Primary Device ID: 00840097524450
• NIH Device Record Key: 92853da0-16f5-4c52-b847-a59a46209ca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ossera™ AFX Instrumentation
• Version Model Number: 6742-4660-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: 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	00840097524450 [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

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

[00840097524450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Ossera™ AFX Instrumentation]

• 00840097524474: Ossera™ AFX Trial, Pill, 46x64
• 00840097524467: Ossera™ AFX Trial, Pill, 46x62
• 00840097524450: Ossera™ AFX Trial, Pill, 46x60
• 00840097524443: Ossera™ AFX Trial, Pill, 46x58
• 00840097524436: Ossera™ AFX Trial, Pill, 46x56
• 00840097524429: Ossera™ AFX Trial, Pill, 46x54
• 00840097524412: Ossera™ AFX Trial, Pill, 46x52
• 00840097524405: Ossera™ AFX Trial, Pill, 46x50
• 00840097524399: Ossera™ AFX Trial, Pill, 46x48
• 00840097524382: Ossera™ AFX Trial, Pill, 44x74
• 00840097524375: Ossera™ AFX Trial, Pill, 44x72
• 00840097524368: Ossera™ AFX Trial, Pill, 44x70
• 00840097524351: Ossera™ AFX Trial, Pill, 44x68
• 00840097524344: Ossera™ AFX Trial, Pill, 44x66
• 00840097524337: Ossera™ AFX Trial, Pill, 44x64
• 00840097524320: Ossera™ AFX Trial, Pill, 44x62
• 00840097524313: Ossera™ AFX Trial, Pill, 44x60
• 00840097524306: Ossera™ AFX Trial, Pill, 44x58
• 00840097524290: Ossera™ AFX Trial, Pill, 44x56
• 00840097524283: Ossera™ AFX Trial, Pill, 44x54
• 00840097524276: Ossera™ AFX Trial, Pill, 44x52
• 00840097524269: Ossera™ AFX Trial, Pill, 44x50