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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 K223065
Device Name Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
Applicant
Adcura, Inc.
11010 Prairie Lakes Dr. Suite 375
Eden Prairie,  MN  55344
Applicant Contact Andrew Rogers
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/30/2022
Decision Date 10/26/2022
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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