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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, Cervical
510(k) Number K190291
Device Name Addivation Medical Cervical Interbody System
Applicant
Addivation Medical, LLC
44 Riverdale Ave.
Monmouth Beach,  NJ  07750
Applicant Contact Gregory Stebbins
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/11/2019
Decision Date 07/30/2019
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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