ADI Cervical Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

Additive Device, Inc. (ADI) D/b/a Restor3d

The following data is part of a premarket notification filed by Additive Device, Inc. (adi) D/b/a Restor3d with the FDA for Adi Cervical Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K191812
• 510k Number: K191812
• Device Name: ADI Cervical Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St Durham, NC 27701
• Contact: Nathan Evans
• Correspondent: Nathan Evans; Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St Durham, NC 27701
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-05
• Decision Date: 2019-10-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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