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FDA 510(k)

Centurion POCT System

K-Number: K180025 · 2018-01-22

ApplicantOrthofix, Inc.
Decision Date2018-01-22
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Centurion POCT System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2018-01-22 under 510(k) number K180025. 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 Centurion POCT System?

Centurion POCT System is a medical device that received FDA 510(k) clearance on 2018-01-22. The listed applicant is Orthofix, Inc.. The 510(k) number is K180025.

When did Centurion POCT System receive FDA 510(k) clearance?

Centurion POCT System received FDA 510(k) clearance on 2018-01-22, under 510(k) number K180025.

Who is the listed applicant for Centurion POCT System?

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

What is the FDA product code for Centurion POCT System?

The FDA product code for Centurion POCT System is NKG.

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NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

Other records listing Orthofix, 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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