Ossera™ AFX Instrumentation

GUDID 00840097514178

Ossera™ AFX Trial, Cylinder, 36x20

Restor3d, Inc.

Surgical implant template, single-use

• Primary Device ID: 00840097514178
• NIH Device Record Key: bd46dcf4-554d-47a6-af58-66dc9edd32a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ossera™ AFX Instrumentation
• Version Model Number: 6740-3620-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	00840097514178 [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

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

Moist Heat or Steam Sterilization

[00840097514178]

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]

• 00840097532219: Ossera™ AFX Trial, Rectangle C01, 34x26x30
• 00840097532202: Ossera™ AFX Trial, Rectangle C01, 34x26x26
• 00840097527215: Ossera™ AFX Trial, Rectangle, 52x34x74
• 00840097527208: Ossera™ AFX Trial, Rectangle, 52x34x72
• 00840097527192: Ossera™ AFX Trial, Rectangle, 52x34x70
• 00840097527185: 6744-5268-N
• 00840097527178: Ossera™ AFX Trial, Rectangle, 52x34x66
• 00840097527161: 6744-5264-N
• 00840097527154: Ossera™ AFX Trial, Rectangle, 52x34x62
• 00840097527147: Ossera™ AFX Trial, Rectangle, 52x34x60
• 00840097527130: Ossera™ AFX Trial, Rectangle, 52x34x58
• 00840097527123: Ossera™ AFX Trial, Rectangle, 52x34x56
• 00840097527116: Ossera™ AFX Trial, Rectangle, 52x34x54
• 00840097527109: Ossera™ AFX Trial, Rectangle, 52x34x52
• 00840097527093: Ossera™ AFX Trial, Rectangle, 52x34x50
• 00840097527086: Ossera™ AFX Trial, Rectangle, 52x34x48
• 00840097527079: Ossera™ AFX Trial, Rectangle, 52x34x22
• 00840097527062: Ossera™ AFX Trial, Rectangle, 52x34x20
• 00840097527055: Ossera™ AFX Trial, Rectangle, 52x34x18
• 00840097527048: Ossera™ AFX Trial, Rectangle, 52x34x16
• 00840097527031: Ossera™ AFX Trial, Rectangle, 52x34x14
• 00840097527024: Ossera™ AFX Trial, Rectangle, 48x34x74
• 00840097527017: Ossera™ AFX Trial, Rectangle, 48x34x72
• 00840097527000: Ossera™ AFX Trial, Rectangle, 48x34x70
• 00840097526997: Ossera™ AFX Trial, Rectangle, 48x34x68
• 00840097526980: Ossera™ AFX Trial, Rectangle, 48x34x66
• 00840097526973: Ossera™ AFX Trial, Rectangle, 48x34x64
• 00840097526966: Ossera™ AFX Trial, Rectangle, 48x34x62
• 00840097526959: Ossera™ AFX Trial, Rectangle, 48x34x60
• 00840097526942: Ossera™ AFX Trial, Rectangle, 48x34x58
• 00840097526935: Ossera™ AFX Trial, Rectangle, 48x34x56
• 00840097526928: Ossera™ AFX Trial, Rectangle, 48x34x54
• 00840097526911: Ossera™ AFX Trial, Rectangle, 48x34x52
• 00840097526904: Ossera™ AFX Trial, Rectangle, 48x34x50
• 00840097526898: Ossera™ AFX Trial, Rectangle, 48x34x48
• 00840097526881: Ossera™ AFX Trial, Rectangle, 48x34x22
• 00840097526874: Ossera™ AFX Trial, Rectangle, 48x34x20
• 00840097526867: Ossera™ AFX Trial, Rectangle, 48x34x18
• 00840097526850: Ossera™ AFX Trial, Rectangle, 48x34x16
• 00840097526843: Ossera™ AFX Trial, Rectangle, 48x34x14
• 00840097526836: Ossera™ AFX Trial, Rectangle, 44x34x74
• 00840097526829: Ossera™ AFX Trial, Rectangle, 44x34x72
• 00840097526812: Ossera™ AFX Trial, Rectangle, 44x34x70
• 00840097526805: Ossera™ AFX Trial, Rectangle, 44x34x68
• 00840097526799: Ossera™ AFX Trial, Rectangle, 44x34x66
• 00840097526782: Ossera™ AFX Trial, Rectangle, 44x34x64
• 00840097526775: Ossera™ AFX Trial, Rectangle, 44x34x62
• 00840097526768: Ossera™ AFX Trial, Rectangle, 44x34x60
• 00840097526751: 6744-5058-N
• 00840097526744: Ossera™ AFX Trial, Rectangle, 44x34x56