restor3d Osteotomy Wedge

GUDID 00840097500157

Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 8mm Thickness

Restor3d

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00840097500157
• NIH Device Record Key: c847c56d-aea2-4042-8fc4-8ba80b5b4bb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Osteotomy Wedge
• Version Model Number: 1101-22200818
• Company DUNS: 080819836
• Company Name: Restor3d
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097500157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191047

FDA Product Code

• PLF: Bone Wedge

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: 2019-12-24
• Device Publish Date: 2019-12-16

On-Brand Devices [restor3d Osteotomy Wedge]

• 00840097500355: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Medium Footprint, 6mm Thickness
• 00840097500348: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Medium Footprint, 5mm Thickness
• 00840097500331: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Medium Footprint, 4mm Thickness
• 00840097500324: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Small Footprint, 6mm Thickness
• 00840097500317: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Small Footprint, 5mm Thickness
• 00840097500300: Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Small Footprint, 4mm Thickness
• 00840097500294: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 12mm Thickness
• 00840097500287: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 10mm Thickness
• 00840097500270: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 8mm Thickness
• 00840097500263: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 6mm Thickness
• 00840097500256: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 12mm Thickness
• 00840097500249: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 10mm Thickness
• 00840097500232: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 8mm Thickness
• 00840097500225: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 6mm Thickness
• 00840097500218: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 12mm Thickness
• 00840097500201: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 10mm Thickness
• 00840097500195: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 8mm Thickness
• 00840097500188: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 6mm Thickness
• 00840097500171: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 12mm Thickness
• 00840097500164: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 10mm Thickness
• 00840097500157: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 8mm Thickness
• 00840097500140: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 12mm Thickness
• 00840097500133: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 10mm Thickness
• 00840097500126: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 8mm Thickness
• 00840097500119: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 12mm Thickness
• 00840097500102: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 10mm Thickness
• 00840097500096: Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 8mm Thickness
• 00840097500089: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 6mm Thickness
• 00840097500072: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 5mm Thickness
• 00840097500065: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 4mm Thickness
• 00840097500058: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 6mm Thickness
• 00840097500041: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 5mm Thickness
• 00840097500034: Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 4mm Thickness
• 00840097502519: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Medium Footprint, 6mm Thickness
• 00840097502502: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Medium Footprint, 5mm Thickness
• 00840097502496: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Medium Footprint, 4mm Thickness
• 00840097502489: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 6mm Thickness
• 00840097502472: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 5mm Thickness
• 00840097502465: Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 4mm Thickness
• 00840097502892: Titanium (Ti-6Al-4V) Evans Wedge 009, Large Footprint, 12mm Thickness
• 00840097502885: Titanium (Ti-6Al-4V) Evans Wedge 009, Large Footprint, 10mm Thickness
• 00840097502878: Titanium (Ti-6Al-4V) Evans Wedge 009, Large Footprint, 8mm Thickness
• 00840097502861: Titanium (Ti-6Al-4V) Evans Wedge 009, Medium Footprint, 12mm Thickness
• 00840097502854: Titanium (Ti-6Al-4V) Evans Wedge 009, Medium Footprint, 10mm Thickness
• 00840097502847: Titanium (Ti-6Al-4V) Evans Wedge 009, Medium Footprint, 8mm Thickness
• 00840097502830: Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 12mm Thickness
• 00840097502823: Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 10mm Thickness
• 00840097502816: Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 8mm Thickness
• 00840097502809: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 8mm Thickness
• 00840097502793: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 6mm Thickness