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FDA 510(k)

Centurion POCT System

K-Number: K201481 · 2020-06-15

ApplicantOrthofix, Inc.
Decision Date2020-06-15
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 2020-06-15 under approval number K201481. 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 2020-06-15. It is manufactured by Orthofix, Inc.. The 510(k) number is K201481.

When was Centurion POCT System approved by the FDA?

Centurion POCT System received FDA 510(k) clearance on 2020-06-15, under approval number K201481.

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.

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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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