FDA 510(k)

neon3 universal OCT spinal stabilization

K-Number: K161032 · 2016-12-22

Decision Date2016-12-22

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

neon3 universal OCT spinal stabilization is a medical device manufactured by Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2016-12-22 under approval number K161032. 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 neon3 universal OCT spinal stabilization?

neon3 universal OCT spinal stabilization is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Ulrich GmbH & Co. KG. The 510(k) number is K161032.

When was neon3 universal OCT spinal stabilization approved by the FDA?

neon3 universal OCT spinal stabilization received FDA 510(k) clearance on 2016-12-22, under approval number K161032.

What company makes neon3 universal OCT spinal stabilization?

neon3 universal OCT spinal stabilization is manufactured by Ulrich GmbH & Co. KG.

What is the FDA product code for neon3 universal OCT spinal stabilization?

The FDA product code for neon3 universal OCT spinal stabilization is NKG.

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Related Devices (Code: NKG)

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.) K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED 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.