Cleared Traditional

RIGEL? 3DR Anterior Cervical Corpectomy System

K232481 · MiRus, LLC · Orthopedic

Oct 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K232481 is an FDA 510(k) clearance for the RIGEL? 3DR Anterior Cervical Corpectomy System, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on October 13, 2023, 58 days after receiving the submission on August 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K232481 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2023
Decision Date	October 13, 2023
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.