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FDA 510(k)

Poseidon OCT Spinal Fixation System

K-Number: K161637 · 2017-01-05

ApplicantMedyssey USA, Inc.
Decision Date2017-01-05
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Poseidon OCT Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K161637. 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 Poseidon OCT Spinal Fixation System?

Poseidon OCT Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K161637.

When did Poseidon OCT Spinal Fixation System receive FDA 510(k) clearance?

Poseidon OCT Spinal Fixation System received FDA 510(k) clearance on 2017-01-05, under 510(k) number K161637.

Who is the listed applicant for Poseidon OCT Spinal Fixation System?

The FDA 510(k) record lists Medyssey USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Poseidon OCT Spinal Fixation System?

The FDA product code for Poseidon OCT Spinal Fixation System is NKG.

Other records listing Medyssey USA, Inc. 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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