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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, Cervical
510(k) Number K223190
Device Name Hive™ Standalone Cervical System
Applicant
NanoHive Medical, LLC
12 Gill St., Suite 4500
Woburn,  MA  01801
Applicant Contact Ian Helmar
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received10/13/2022
Decision Date 12/12/2022
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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