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FDA 510(k)

DOLOMITE Anterior Cervical Stabilization System

K-Number: K202065 · 2020-10-26

ApplicantAstura Medical, LLC
Decision Date2020-10-26
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DOLOMITE Anterior Cervical Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2020-10-26 under 510(k) number K202065. 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 DOLOMITE Anterior Cervical Stabilization System?

DOLOMITE Anterior Cervical Stabilization System is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Astura Medical, LLC. The 510(k) number is K202065.

When did DOLOMITE Anterior Cervical Stabilization System receive FDA 510(k) clearance?

DOLOMITE Anterior Cervical Stabilization System received FDA 510(k) clearance on 2020-10-26, under 510(k) number K202065.

Who is the listed applicant for DOLOMITE Anterior Cervical Stabilization System?

The FDA 510(k) record lists Astura Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOLOMITE Anterior Cervical Stabilization System?

The FDA product code for DOLOMITE Anterior Cervical Stabilization System is OVE.

Related Clinical Trials

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.

NCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

Other records listing Astura Medical, LLC as applicant

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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

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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