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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 the device name listed in this FDA 510(k) record. The listed applicant is Additive Implants, Inc.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) 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. The listed applicant is Additive Implants, Inc.. The 510(k) number is K211111.

When did SureMAX-SA Cervical Standalone System receive FDA 510(k) clearance?

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

Who is the listed applicant for SureMAX-SA Cervical Standalone System?

The FDA 510(k) record lists Additive Implants, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Additive Implants, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193359SureMAX Family of Cervical SpacersK182477Cervical Spacer

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

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

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