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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 K210542
Device Name aprevo Transforaminal IBF
Applicant
Carlsmed, Inc.
4250 Executive Sq., Suite 675
La Jolla,  CA  92037
Applicant Contact Karen Liu
Correspondent
Carlsmed, Inc.
4250 Executive Sq., Suite 675
La Jolla,  CA  92037
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/24/2021
Decision Date 06/30/2021
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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