FDA 510(k)

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

K-Number: K252885 · 2026-01-22

Decision Date2026-01-22

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2026-01-22 under approval number K252885. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Astura Medical. The 510(k) number is K252885.

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

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System received FDA 510(k) clearance on 2026-01-22, under approval number K252885.

What company makes OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is manufactured by Astura Medical.

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

The FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is PML.

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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

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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.