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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 K193359
Device Name SureMAX Family of Cervical Spacers
Applicant
Additive Implants, Inc.
3101 E. Shea Blvd.
Suite 122
Phoenix,  AZ  85028
Applicant Contact Jeff Horn
Correspondent
Backroads Consulting
12520 Heath Rd.
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
ODP  
Date Received12/04/2019
Decision Date 01/03/2020
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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