Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Prase MIS Spinal System

K-Number: K182059 · 2018-10-04

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2018-10-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prase MIS Spinal System is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2018-10-04 under approval number K182059. 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 Prase MIS Spinal System?

Prase MIS Spinal System is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K182059.

When was Prase MIS Spinal System approved by the FDA?

Prase MIS Spinal System received FDA 510(k) clearance on 2018-10-04, under approval number K182059.

What company makes Prase MIS Spinal System?

Prase MIS Spinal System is manufactured by Gbs Commonwealth Co., Ltd..

What is the FDA product code for Prase MIS Spinal System?

The FDA product code for Prase MIS Spinal System is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults 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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED

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 Gbs Commonwealth Co., Ltd.

K173645JASPER Spinal Fixation System K192026Peridot Intervertebral body fusion System K190762The JASPER Spinal Fixation System II K211205Prase-C Anterior Cervical Plate System K202872Prase PEEK Anterior Cervical Interbody Spacer K202878Prase-AP Anterior Cervical Plate System

View all 14 devices →

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.

↑