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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K180675
Device Name Atlas Spine Expandable Cervical Interbody System
Applicant
Atlas Spine, Inc.
1555 Jupiter Park Dr.
Suite 1
Jupiter,  FL  33458
Applicant Contact Thomas Smith
Correspondent
Empirical Consulting, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/15/2018
Decision Date 06/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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