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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 K242260
Device Name aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
Applicant
Carlsmed, Inc
1800 Aston Ave., Ste. 100
Carlsbad,  CA  92008
Applicant Contact Karen Liu
Correspondent
Carlsmed, Inc
1800 Aston Ave., Ste. 100
Carlsbad,  CA  92008
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received07/31/2024
Decision Date 11/15/2024
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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