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neon3 Universal OCT Spinal Stabilization

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161032

by ulrich GmbH & Co. KG

Identifiers

510(k) Number
K161032 FDA 510(k)
FDA Product Code
NKG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3075 FDA 510(k)
Regulation Number
888.3075 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The neon3 Universal OCT Spinal Stabilization is a spinal fixation device designed for orthopedic applications. It provides temporary stabilization of the spine during surgical procedures, particularly in cases involving spinal fusion or decompression, by securing vertebrae in the desired position using octagonal cross-section (OCT) technology.

This device is supplied as a reusable medical instrument, intended for use in operating room settings. It is classified under the product code NKG and has received FDA 510(k) clearance as Substantially Equivalent under the Traditional pathway, with authorization also granted under the Medical Device Regulation (MDR). The device is manufactured by Ulrich GmbH & Co. KG, based in Ulm, Germany.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
ulrich GmbH & Co. KG

Sources (2)

  • FDA 510(k) K161032 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026