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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 K230478
Device Name Acro Composites Interbody System
Applicant
Acro Composites, LLC
6950 W Snowville Rd.
Brecksville,  OH  44141
Applicant Contact Mitchell Bass
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received02/22/2023
Decision Date 10/19/2023
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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