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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 Integrated Fixation, Lumbar
510(k) Number K243191
Device Name Atlas Spine Lateral Expandable Interbody System
Applicant
Atlas Spine, Inc.
1555 Jupiter Park Dr.
Suite 1
Jupiter,  FL  33458
Applicant Contact Thomas Smith
Correspondent
Atlas Spine, Inc.
1555 Jupiter Park Dr.
Suite 1
Jupiter,  FL  33458
Correspondent Contact Thomas Smith
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   PHM  
Date Received09/30/2024
Decision Date 11/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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