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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 K202034
Device Name aprevo Intervertebral Body Fusion Device
Applicant
Carlsmed, Inc.
4250 Executive Sq. Ste. 200
La Jolla,  CA  92037
Applicant Contact Mike Cordonnier
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/23/2020
Decision Date 12/03/2020
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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