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FDA 510(k)

RIGEL PEEK Anterior Cervical Interbody Fusion System

K-Number: K190618 · 2019-06-06

ApplicantMiRus, LLC
Decision Date2019-06-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIGEL PEEK Anterior Cervical Interbody Fusion System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2019-06-06 under approval number K190618. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGEL PEEK Anterior Cervical Interbody Fusion System?

RIGEL PEEK Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-06. It is manufactured by MiRus, LLC. The 510(k) number is K190618.

When was RIGEL PEEK Anterior Cervical Interbody Fusion System approved by the FDA?

RIGEL PEEK Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-06, under approval number K190618.

What company makes RIGEL PEEK Anterior Cervical Interbody Fusion System?

RIGEL PEEK Anterior Cervical Interbody Fusion System is manufactured by MiRus, LLC.

What is the FDA product code for RIGEL PEEK Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL PEEK Anterior Cervical Interbody Fusion System is ODP.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

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

Other Devices by MiRus, LLC

K182989AURORA™ Screw System K192268Europa Pedicle Screw System K191757EUROPA Pedicle Screw System K182524GALILEO Spine Alignment Monitoring System K190666CYGNUS™ Anterior Cervical Plate System K190415ATLAS Plating System

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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