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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 Integrated Fixation, Lumbar
510(k) Number K222561
Device Name Align
Applicant
Acuity Surgical Devices, LLC
8710 N. Royal Lane
Irving,  TX  75063
Applicant Contact Bryan Cowan
Correspondent
RQM+
2251 San Diego Ave. B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received08/24/2022
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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