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FDA 510(k)

SureMAX Family of Cervical Spacers

K-Number: K193359 · 2020-01-03

ApplicantAdditive Implants, Inc.
Decision Date2020-01-03
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SureMAX Family of Cervical Spacers is a medical device manufactured by Additive Implants, Inc.. It received FDA 510(k) clearance on 2020-01-03 under approval number K193359. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureMAX Family of Cervical Spacers?

SureMAX Family of Cervical Spacers is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Additive Implants, Inc.. The 510(k) number is K193359.

When was SureMAX Family of Cervical Spacers approved by the FDA?

SureMAX Family of Cervical Spacers received FDA 510(k) clearance on 2020-01-03, under approval number K193359.

What company makes SureMAX Family of Cervical Spacers?

SureMAX Family of Cervical Spacers is manufactured by Additive Implants, Inc..

What is the FDA product code for SureMAX Family of Cervical Spacers?

The FDA product code for SureMAX Family of Cervical Spacers is ODP.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

Other Devices by Additive Implants, Inc.

K211111SureMAX-SA Cervical Standalone System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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