FDA 510(k)

Statera-C Spinal System

K-Number: K233332 · 2023-11-27

Decision Date2023-11-27

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Statera-C Spinal System is a medical device manufactured by K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-11-27 under approval number K233332. 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 Statera-C Spinal System?

Statera-C Spinal System is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by K&J Consulting Corp.. The 510(k) number is K233332.

When was Statera-C Spinal System approved by the FDA?

Statera-C Spinal System received FDA 510(k) clearance on 2023-11-27, under approval number K233332.

What company makes Statera-C Spinal System?

Statera-C Spinal System is manufactured by K&J Consulting Corp..

What is the FDA product code for Statera-C Spinal System?

The FDA product code for Statera-C Spinal System is NKG.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by K&J Consulting Corp.

K232586Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.