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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 K230639
Device Name Align Cervical Interbody Fusion System
Applicant
Acuity Surgical Devices, LLC
8710 N. Royal Ln.
Irving,  TX  75063
Applicant Contact Bryan Cowan
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/08/2023
Decision Date 12/01/2023
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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