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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 K201671
Device Name A-Link Z
Applicant
Acuity Surgical Devices, LLC
8710 N. Royal Ln.
Irving,  TX  75063
Applicant Contact Bryan Cowan
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Regulation Number888.3080
Classification Product Code
OVD  
Date Received06/19/2020
Decision Date 05/04/2021
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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