Ossera™ AFX

GUDID 00840097516691

Ossera™ AFX, Cylinder, 38x44

Restor3d, Inc.

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840097516691
• NIH Device Record Key: 72b4f928-1f20-48ae-a2b5-043ba50b6be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ossera™ AFX
• Version Model Number: 1740-3844-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	00840097516691 [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

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

Moist Heat or Steam Sterilization

[00840097516691]

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]

• 00840097530482: Ossera™ AFX, Half Pill, 46x74
• 00840097530475: Ossera™ AFX, Half Pill, 46x72
• 00840097530468: Ossera™ AFX, Half Pill, 46x70
• 00840097530451: Ossera™ AFX, Half Pill, 46x68
• 00840097530444: Ossera™ AFX, Half Pill, 46x66
• 00840097530437: Ossera™ AFX, Half Pill, 46x64
• 00840097530420: Ossera™ AFX, Half Pill, 46x62
• 00840097530413: Ossera™ AFX, Half Pill, 46x60
• 00840097530406: Ossera™ AFX, Half Pill, 46x58
• 00840097530390: Ossera™ AFX, Half Pill, 46x56
• 00840097530383: Ossera™ AFX, Half Pill, 46x54
• 00840097530376: Ossera™ AFX, Half Pill, 46x52
• 00840097530369: Ossera™ AFX, Half Pill, 46x50
• 00840097530352: Ossera™ AFX, Half Pill, 46x48
• 00840097530345: Ossera™ AFX, Half Pill, 44x74
• 00840097530338: Ossera™ AFX, Half Pill, 44x72
• 00840097530321: Ossera™ AFX, Half Pill, 44x70
• 00840097530314: Ossera™ AFX, Half Pill, 44x68
• 00840097530307: Ossera™ AFX, Half Pill, 44x66
• 00840097530291: Ossera™ AFX, Half Pill, 44x64
• 00840097530284: Ossera™ AFX, Half Pill, 44x62
• 00840097530277: Ossera™ AFX, Half Pill, 44x60
• 00840097530260: Ossera™ AFX, Half Pill, 44x58
• 00840097530253: Ossera™ AFX, Half Pill, 44x56
• 00840097530246: Ossera™ AFX, Half Pill, 44x54
• 00840097530239: Ossera™ AFX, Half Pill, 44x52
• 00840097530222: Ossera™ AFX, Half Pill, 44x50
• 00840097530215: Ossera™ AFX, Half Pill, 44x48
• 00840097530208: Ossera™ AFX, Half Pill, 42x74
• 00840097530192: Ossera™ AFX, Half Pill, 42x72
• 00840097530185: Ossera™ AFX, Half Pill, 42x70
• 00840097530178: Ossera™ AFX, Half Pill, 42x68
• 00840097530161: Ossera™ AFX, Half Pill, 42x66
• 00840097530154: Ossera™ AFX, Half Pill, 42x64
• 00840097530147: Ossera™ AFX, Half Pill, 42x62
• 00840097530130: Ossera™ AFX, Half Pill, 42x60
• 00840097530123: Ossera™ AFX, Half Pill, 42x58
• 00840097530116: Ossera™ AFX, Half Pill, 42x56
• 00840097530109: Ossera™ AFX, Half Pill, 42x54
• 00840097530093: Ossera™ AFX, Half Pill, 42x52
• 00840097530086: Ossera™ AFX, Half Pill, 42x50
• 00840097530079: Ossera™ AFX, Half Pill, 42x48
• 00840097530062: Ossera™ AFX, Half Pill, 40x74
• 00840097530055: Ossera™ AFX, Half Pill, 40x72
• 00840097530048: Ossera™ AFX, Half Pill, 40x70
• 00840097530031: Ossera™ AFX, Half Pill, 40x68
• 00840097530024: Ossera™ AFX, Half Pill, 40x66
• 00840097530017: Ossera™ AFX, Half Pill, 40x64
• 00840097530000: Ossera™ AFX, Half Pill, 40x62
• 00840097529998: Ossera™ AFX, Half Pill, 40x60