Cleared Traditional

DOMINION Expandable Corpectomy System

K233359 · Astura Medical · Orthopedic
Mar 2024
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K233359 is an FDA 510(k) clearance for the DOMINION Expandable Corpectomy System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on March 8, 2024, 161 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K233359 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date March 08, 2024
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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