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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K223808
Device Name Zavation Navigation Instrument System
Applicant
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Applicant Contact Katie Motley
Correspondent
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Correspondent Contact Katie Motley
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/20/2022
Decision Date 07/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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