SureMAX Family Of Cervical Spacers

Intervertebral Fusion Device With Bone Graft, Cervical

Additive Implants, Inc

The following data is part of a premarket notification filed by Additive Implants, Inc with the FDA for Suremax Family Of Cervical Spacers.

Pre-market Notification Details

Device IDK193359
510k NumberK193359
Device Name:SureMAX Family Of Cervical Spacers
ClassificationIntervertebral Fusion Device With Bone Graft, 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 CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-01-03

NIH GUDID Devices

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