FDA 510(k)

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System

K-Number: K232586 · 2023-10-24

Decision Date2023-10-24

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System is a medical device manufactured by K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-10-24 under approval number K232586. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System?

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by K&J Consulting Corp.. The 510(k) number is K232586.

When was Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System approved by the FDA?

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System received FDA 510(k) clearance on 2023-10-24, under approval number K232586.

What company makes Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System?

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System is manufactured by K&J Consulting Corp..

What is the FDA product code for Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System?

The FDA product code for Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by K&J Consulting Corp.

K233332Statera-C 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: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.