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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K252611
Device Name aprevo® cervical plating system
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92130
Applicant Contact Jesse Albright
Correspondent
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92130
Correspondent Contact Jesse Albright
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/18/2025
Decision Date 12/22/2025
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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