SureMAX-SA Cervical Standalone System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Additive Implants, Inc

The following data is part of a premarket notification filed by Additive Implants, Inc with the FDA for Suremax-sa Cervical Standalone System.

Pre-market Notification Details

Device IDK211111
510k NumberK211111
Device Name:SureMAX-SA Cervical Standalone System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Additive Implants, Inc 3101 E. Shea Blvd, Suite 122 Phoenix,  AZ  85028
ContactJeff Horn
CorrespondentKaren E Warden
BackRoads Consulting 12520 Heath Road Chesterland,  OH  44026
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-14
Decision Date2021-07-16

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