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FDA 510(k)

MiRus MoRe Lumbar Plating System

K-Number: K241175 · 2024-05-17

ApplicantMiRus, LLC
Decision Date2024-05-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MiRus MoRe Lumbar Plating System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2024-05-17 under approval number K241175. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiRus MoRe Lumbar Plating System?

MiRus MoRe Lumbar Plating System is a medical device that received FDA 510(k) clearance on 2024-05-17. It is manufactured by MiRus, LLC. The 510(k) number is K241175.

When was MiRus MoRe Lumbar Plating System approved by the FDA?

MiRus MoRe Lumbar Plating System received FDA 510(k) clearance on 2024-05-17, under approval number K241175.

What company makes MiRus MoRe Lumbar Plating System?

MiRus MoRe Lumbar Plating System is manufactured by MiRus, LLC.

What is the FDA product code for MiRus MoRe Lumbar Plating System?

The FDA product code for MiRus MoRe Lumbar Plating System is KWQ.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

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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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