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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K252822
Device Name Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
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 Patrick Kennedy
Regulation Number888.3060
Classification Product Code
PLR  
Date Received09/04/2025
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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