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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 K210155
Device Name Duo Expandable Interbody Fusion System
Applicant
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Applicant Contact Andrew Adams
Correspondent
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Correspondent Contact Andrew Adams
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/21/2021
Decision Date 02/19/2021
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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