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FDA 510(k)

OLYMPIC Posterior Spinal Fixation System

K-Number: K153446 · 2016-04-08

ApplicantAstura Medical
Decision Date2016-04-08
Product CodeOSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Posterior Spinal Fixation System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2016-04-08 under approval number K153446. The device is classified under product code OSH. 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 2016-04-08. It is manufactured by Astura Medical. The 510(k) number is K153446.

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

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2016-04-08, under approval number K153446.

What company makes OLYMPIC Posterior Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System is manufactured by Astura Medical.

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

The FDA product code for OLYMPIC Posterior Spinal Fixation System is OSH.

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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

K160702ZION Anterior Cervical Fixation System K160154ALTA Anterior Cervical Interbody Spacer K152512Half Dome Posterior Lumbar Interbody System K171250BRIDALVEIL Occipital Cervical Thoracic System K163481HALF DOME Posterior Lumbar Interbody System K172166OLYMPIC Navigated Instruments

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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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