restor3d Utility Wedge

GUDID 00840097504988

Ti Anatomic Evans Wedge, Medium Footprint, 8mm Thickness

Restor3d

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00840097504988
• NIH Device Record Key: ad419442-f30a-4059-8a6c-b61cef820435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Utility Wedge
• Version Model Number: 1101-010-202008
• 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	00840097504988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201314

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: 2022-11-30
• Device Publish Date: 2022-11-22

On-Brand Devices [restor3d Utility Wedge]

• 00840097503592: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 10 Degree
• 00840097503585: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 5 Degree
• 00840097503578: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 0 Degree
• 00840097503561: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 10 Degree
• 00840097503554: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 5 Degree
• 00840097503547: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 0 Degree
• 00840097503530: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 10 Degree
• 00840097503523: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 5 Degree
• 00840097503516: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 0 Degree
• 00840097503509: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 10 Degree
• 00840097503493: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 5 Degree
• 00840097503486: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 0 Degree
• 00840097503479: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 10 Degree
• 00840097503462: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 5 Degree
• 00840097503455: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 0 Degree
• 00840097503448: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 10 Degree
• 00840097503431: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 5 Degree
• 00840097503424: Titanium (Ti-6AL-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 0 Degree
• 00840097503417: Titanium (Ti-6AL-4V) Subtalar Wedge, Right Foot, Small Footprint, 14mm Thickness, 10 Degree
• 00840097503400: Titanium (Ti-6AL-4V) Subtalar Wedge, Right Foot, Small Footprint, 14mm Thickness, 5 Degree
• 00840097503394: Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 14mm Thickness, 0 Degree
• 00840097503387: Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 12mm Thickness,10 Degree
• 00840097503370: Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 12mm Thickness, 5 Degree
• 00840097503363: Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 12mm Thickness, 0 Degree
• 00840097503356: Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 10 Degree
• 00840097503349: Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 5 Degree
• 00840097503332: Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 0 Degree
• 00840097503325: Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 10 Degree
• 00840097503318: Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 5 Degree
• 00840097503301: Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 0 Degree
• 00840097503295: Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 10 Degree
• 00840097503288: Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 5 Degree
• 00840097503271: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 0 Degree
• 00840097503264: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 10 Degree
• 00840097503257: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 5 Degree
• 00840097503240: Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 0 Degree
• 00840097505046: Ti Anatomic Evans Wedge, Large Footprint, 12mm Thickness
• 00840097505039: Ti Anatomic Evans Wedge, Large Footprint, 10mm Thickness
• 00840097505022: Ti Anatomic Evans Wedge, Large Footprint, 8mm Thickness
• 00840097505015: Ti Anatomic Evans Wedge, Large Footprint, 6mm Thickness
• 00840097505008: Ti Anatomic Evans Wedge, Medium Footprint, 12mm Thickness
• 00840097504995: Ti Anatomic Evans Wedge, Medium Footprint, 10mm Thickness
• 00840097504988: Ti Anatomic Evans Wedge, Medium Footprint, 8mm Thickness
• 00840097504971: Ti Anatomic Evans Wedge, Medium Footprint, 6mm Thickness
• 00840097504964: Ti Anatomic Evans Wedge, Small Footprint, 12mm Thickness
• 00840097504957: Ti Anatomic Evans Wedge, Small Footprint, 10mm Thickness
• 00840097504940: Ti Anatomic Evans Wedge, Small Footprint, 8mm Thickness
• 00840097504933: Ti Anatomic Evans Wedge, Small Footprint, 6mm Thickness