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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 K243802
Device Name aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Applicant Contact Karen Liu
Correspondent
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received12/11/2024
Decision Date 03/17/2025
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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