restor3d Osteotomy Wedge

GUDID 00840097503097

Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 7mm Thickness

Restor3d, Inc.

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840097503097
• NIH Device Record Key: a1e0d8b4-7d45-47f4-9f65-87d17314845c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Osteotomy Wedge
• Version Model Number: 1100-002-22140707
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097503097 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-02
• Device Publish Date: 2021-09-01

On-Brand Devices [restor3d Osteotomy Wedge]

• 00840097503103: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 8mm Thickness
• 00840097503097: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 7mm Thickness
• 00840097503080: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 6mm Thickness
• 00840097503073: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 5mm Thickness
• 00840097503028: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 10mm Thickness
• 00840097503011: Titanium (Ti-6Al-4V) Cotton Wedge 002, Anatomic Footprint, 9mm Thickness