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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, Lumbar
510(k) Number K251969
Device Name Atlas Spine Project X Expandable Posterior Lumbar 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
MAX  
Date Received06/26/2025
Decision Date 08/15/2025
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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