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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 K200541
Device Name Hive™ Stand-alone Anterior Lumbar Interbody System
Applicant
Hd Lifesciences, LLC
12 Gill St.
Suite 4500
Woburn,  MA  01801
Applicant Contact John Sullivan
Correspondent
Hd Lifesciences, LLC
12 Gill St.
Suite 4500
Woburn,  MA  01801
Correspondent Contact John Sullivan
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received03/03/2020
Decision Date 04/28/2020
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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