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FDA 510(k)

SYMPHONY OCT System

K-Number: K233366 · 2023-11-09

ApplicantMedos International SARL
Decision Date2023-11-09
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYMPHONY OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K233366. 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 SYMPHONY OCT System?

SYMPHONY OCT System is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Medos International SARL. The 510(k) number is K233366.

When did SYMPHONY OCT System receive FDA 510(k) clearance?

SYMPHONY OCT System received FDA 510(k) clearance on 2023-11-09, under 510(k) number K233366.

Who is the listed applicant for SYMPHONY OCT System?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYMPHONY OCT System?

The FDA product code for SYMPHONY OCT System is NKG.

Related Clinical Trials

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Other records listing Medos International SARL as applicant

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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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