FDA 510(k)

Sovereign Posterior Cervical System

K-Number: K250866 · 2025-05-20

Decision Date2025-05-20

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Sovereign Posterior Cervical System is a medical device manufactured by Met One Technologies, LLC. It received FDA 510(k) clearance on 2025-05-20 under approval number K250866. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sovereign Posterior Cervical System?

Sovereign Posterior Cervical System is a medical device that received FDA 510(k) clearance on 2025-05-20. It is manufactured by Met One Technologies, LLC. The 510(k) number is K250866.

When was Sovereign Posterior Cervical System approved by the FDA?

Sovereign Posterior Cervical System received FDA 510(k) clearance on 2025-05-20, under approval number K250866.

What company makes Sovereign Posterior Cervical System?

Sovereign Posterior Cervical System is manufactured by Met One Technologies, LLC.

What is the FDA product code for Sovereign Posterior Cervical System?

The FDA product code for Sovereign Posterior Cervical System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING

Other Devices by Met One Technologies, LLC

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Related Devices (Code: NKG)

K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.