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FDA 510(k)

Sovereign Posterior Cervical System

K-Number: K250866 · 2025-05-20

ApplicantMet One Technologies, LLC
Decision Date2025-05-20
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sovereign Posterior Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies, LLC. It received FDA 510(k) clearance on 2025-05-20 under 510(k) 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. The listed applicant is Met One Technologies, LLC. The 510(k) number is K250866.

When did Sovereign Posterior Cervical System receive FDA 510(k) clearance?

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

Who is the listed applicant for Sovereign Posterior Cervical System?

The FDA 510(k) record lists Met One Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Met One Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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