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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 K252894
Device Name aprevo® cervical interbody system
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Applicant Contact Jesse Albright
Correspondent
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Correspondent Contact Jesse Albright
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received09/11/2025
Decision Date 01/06/2026
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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