FDA 510(k)

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System

K-Number: K232348 · 2023-10-27

Decision Date2023-10-27

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2023-10-27 under approval number K232348. 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 RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System?

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by MiRus, LLC. The 510(k) number is K232348.

When was RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System approved by the FDA?

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-10-27, under approval number K232348.

What company makes RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System?

RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System is manufactured by MiRus, LLC.

What is the FDA product code for RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System is OVE.

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Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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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.