Atlas Spine Expandable Cervical Interbody System

Intervertebral Fusion Device With Bone Graft, Cervical

Atlas Spine, Inc.

The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Atlas Spine Expandable Cervical Interbody System.

Pre-market Notification Details

• Device ID: K180675
• 510k Number: K180675
• Device Name: Atlas Spine Expandable Cervical Interbody System
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458
• Contact: Thomas Smith
• Correspondent: Meredith May; Empirical Consulting, LLC. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-15
• Decision Date: 2018-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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