Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DOMINION Expandable Corpectomy System

K-Number: K233359 · 2024-03-08

ApplicantAstura Medical
Decision Date2024-03-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DOMINION Expandable Corpectomy System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2024-03-08 under approval number K233359. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOMINION Expandable Corpectomy System?

DOMINION Expandable Corpectomy System is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Astura Medical. The 510(k) number is K233359.

When was DOMINION Expandable Corpectomy System approved by the FDA?

DOMINION Expandable Corpectomy System received FDA 510(k) clearance on 2024-03-08, under approval number K233359.

What company makes DOMINION Expandable Corpectomy System?

DOMINION Expandable Corpectomy System is manufactured by Astura Medical.

What is the FDA product code for DOMINION Expandable Corpectomy System?

The FDA product code for DOMINION Expandable Corpectomy System is MQP.

Related Clinical Trials

NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by Astura Medical

K160702ZION Anterior Cervical Fixation System K160154ALTA Anterior Cervical Interbody Spacer K153446OLYMPIC Posterior Spinal Fixation System K152512Half Dome Posterior Lumbar Interbody System K171250BRIDALVEIL Occipital Cervical Thoracic System K163481HALF DOME Posterior Lumbar Interbody System

View all 21 devices →

Related Devices (Code: MQP)

K172330Blustone Synergy Silica SystemBlustone Synergy K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. K172323Omnia Medical VBROmnia Medical, LLC K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m

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.

↑