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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 a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2020-10-26 under approval 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. It is manufactured by Astura Medical, LLC. The 510(k) number is K202065.

When was DOLOMITE Anterior Cervical Stabilization System approved by the FDA?

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

What company makes DOLOMITE Anterior Cervical Stabilization System?

DOLOMITE Anterior Cervical Stabilization System is manufactured by Astura Medical, LLC.

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

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

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Other Devices by Astura Medical, LLC

K182239OLYMPIC Posterior Spinal Fixation System K181139OLYMPIC Posterior Spinal Fixation System K190426ALTA Anterior Cervical Corpectomy System K182877HALF DOME Posterior Lumbar Interbody System K192492EL CAPITAN Anterior Lumber Interbody System K192006SIRION Lateral Lumbar Interbody System

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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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