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FDA 510(k)

SureMAX-SA Cervical Standalone System

K-Number: K211111 · 2021-07-16

ApplicantAdditive Implants, Inc.
Decision Date2021-07-16
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SureMAX-SA Cervical Standalone System is a medical device manufactured by Additive Implants, Inc.. It received FDA 510(k) clearance on 2021-07-16 under approval number K211111. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureMAX-SA Cervical Standalone System?

SureMAX-SA Cervical Standalone System is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Additive Implants, Inc.. The 510(k) number is K211111.

When was SureMAX-SA Cervical Standalone System approved by the FDA?

SureMAX-SA Cervical Standalone System received FDA 510(k) clearance on 2021-07-16, under approval number K211111.

What company makes SureMAX-SA Cervical Standalone System?

SureMAX-SA Cervical Standalone System is manufactured by Additive Implants, Inc..

What is the FDA product code for SureMAX-SA Cervical Standalone System?

The FDA product code for SureMAX-SA Cervical Standalone System is OVE.

Related Clinical Trials

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Other Devices by Additive Implants, Inc.

K193359SureMAX Family of Cervical Spacers

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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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