FDA 510(k)

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System

K-Number: K180980 · 2018-10-27

Decision Date2018-10-27

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System is a medical device manufactured by Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-10-27 under approval number K180980. 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 ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System?

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System is a medical device that received FDA 510(k) clearance on 2018-10-27. It is manufactured by Camber Spine Technologies, LLC. The 510(k) number is K180980.

When was ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System approved by the FDA?

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System received FDA 510(k) clearance on 2018-10-27, under approval number K180980.

What company makes ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System?

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System is manufactured by Camber Spine Technologies, LLC.

What is the FDA product code for ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System?

The FDA product code for ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING

Other Devices by Camber Spine Technologies, LLC

K180724SPIRA Open Matrix LLIF K191584FORTICO Anterior Cervical Fixation System K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K203503Camber Sacroiliac (SI) Fixation System K232256Alcantara Thoracolumbar 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

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