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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 K243635
Device Name aprevo® anterior lumbar interbody fusion device with interfixation
Applicant
Carlsmed, Inc.
2535 San Clemente Ter
Carlsbad,  CA  92008
Applicant Contact Liu Karen
Correspondent
Carlsmed, Inc.
2535 San Clemente Ter
Carlsbad,  CA  92008
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/25/2024
Decision Date 12/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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