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)

OLYMPIC Posterior Spinal Fixation System

K-Number: K182239 · 2018-10-18

ApplicantAstura Medical, LLC
Decision Date2018-10-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Posterior Spinal Fixation System is a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2018-10-18 under approval number K182239. 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 OLYMPIC Posterior Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Astura Medical, LLC. The 510(k) number is K182239.

When was OLYMPIC Posterior Spinal Fixation System approved by the FDA?

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2018-10-18, under approval number K182239.

What company makes OLYMPIC Posterior Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System is manufactured by Astura Medical, LLC.

What is the FDA product code for OLYMPIC Posterior Spinal Fixation System?

The FDA product code for OLYMPIC Posterior Spinal Fixation 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 NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING

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 Astura Medical, LLC

K181139OLYMPIC Posterior Spinal Fixation System K190426ALTA Anterior Cervical Corpectomy System K182877HALF DOME Posterior Lumbar Interbody System K202065DOLOMITE Anterior Cervical Stabilization System K192492EL CAPITAN Anterior Lumber Interbody System K192006SIRION Lateral Lumbar Interbody System

View all 8 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.

↑