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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 a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2018-01-22 under approval 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. It is manufactured by Orthofix, Inc.. The 510(k) number is K180025.

When was Centurion POCT System approved by the FDA?

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

What company makes Centurion POCT System?

Centurion POCT System is manufactured by Orthofix, Inc..

What is the FDA product code for Centurion POCT System?

The FDA product code for Centurion POCT System is NKG.

Other Devices by Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161129PILLAR SA PTC K161280Cervical Stand Alone System K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System K152475FORZA PTC Spacer System

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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

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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