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FDA 510(k)

OLYMPIC Posterior Spinal Fixation System

K-Number: K181139 · 2018-07-06

ApplicantAstura Medical, LLC
Decision Date2018-07-06
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 2018-07-06 under approval number K181139. 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 2018-07-06. It is manufactured by Astura Medical, LLC. The 510(k) number is K181139.

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

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2018-07-06, under approval number K181139.

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

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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 Astura Medical, LLC

K182239OLYMPIC 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

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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.

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