FDA 510(k)

Saxxony Posterior Cervical Thoracic System

K-Number: K182508 · 2018-11-13

Decision Date2018-11-13

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Saxxony Posterior Cervical Thoracic System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2018-11-13 under approval number K182508. 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 Saxxony Posterior Cervical Thoracic System?

Saxxony Posterior Cervical Thoracic System is a medical device that received FDA 510(k) clearance on 2018-11-13. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K182508.

When was Saxxony Posterior Cervical Thoracic System approved by the FDA?

Saxxony Posterior Cervical Thoracic System received FDA 510(k) clearance on 2018-11-13, under approval number K182508.

What company makes Saxxony Posterior Cervical Thoracic System?

Saxxony Posterior Cervical Thoracic System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for Saxxony Posterior Cervical Thoracic System?

The FDA product code for Saxxony Posterior Cervical Thoracic System is NKG.

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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.