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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, Lumbar
510(k) Number K260385
Device Name aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Applicant Contact Stephanie Crossman
Correspondent
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Correspondent Contact Stephanie Crossman
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWQ   ODP   OVD   OVE  
Date Received02/06/2026
Decision Date 05/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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