Restor3d TiDAL Lumbar Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Restor3d

The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Tidal Lumbar Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K220523
• 510k Number: K220523
• Device Name: Restor3d TiDAL Lumbar Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Restor3d 404 Hunt St. Suite 500 Durham, NC 27701
• Contact: Shyam Patel
• Correspondent: Shyam Patel; Restor3d 404 Hunt St. Suite 500 Durham, NC 27701
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-23
• Decision Date: 2022-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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