restor3d Lumbar Implant

GUDID 00840097508399

Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 12°

Restor3d, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00840097508399
• NIH Device Record Key: 106be1da-868c-4187-acf9-c77bf953a993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Lumbar Implant
• Version Model Number: 1113-L1612
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00840097508399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220523

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-07
• Device Publish Date: 2023-10-30

On-Brand Devices [restor3d Lumbar Implant]

• 00840097508412: Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 18°
• 00840097508405: Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 15°
• 00840097508399: Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 12°
• 00840097508368: Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 18°
• 00840097508351: Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 15°
• 00840097508344: Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 12°
• 00840097508313: Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 18°
• 00840097508306: Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 15°
• 00840097508290: Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 12°
• 00840097508269: Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 18°
• 00840097508252: Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 15°
• 00840097508245: Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 12°
• 00840097508139: Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 18°
• 00840097508122: Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 15°
• 00840097508115: Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 12°
• 00840097508085: Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 18°
• 00840097508078: Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 15°
• 00840097508061: Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 12°
• 00840097508030: Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 18°
• 00840097508023: Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 15°
• 00840097508016: Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 12°
• 00840097507989: Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 18°
• 00840097507972: Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 15°
• 00840097507965: Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 12°
• 00840097507859: Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 18°
• 00840097507842: Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 15°
• 00840097507835: Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 12°
• 00840097507804: Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 18°
• 00840097507798: Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 15°
• 00840097507781: Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 12°
• 00840097507750: Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 18°
• 00840097507743: Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 15°
• 00840097507736: Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 12°
• 00840097507705: Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 18°
• 00840097507699: Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 15°
• 00840097507682: Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 12°