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FDA 510(k)

MASADA Modular Spinal Fixation System

K-Number: K243259 · 2025-01-07

ApplicantAstura Medical
Decision Date2025-01-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MASADA Modular Spinal Fixation System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2025-01-07 under approval number K243259. 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 MASADA Modular Spinal Fixation System?

MASADA Modular Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-01-07. It is manufactured by Astura Medical. The 510(k) number is K243259.

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

MASADA Modular Spinal Fixation System received FDA 510(k) clearance on 2025-01-07, under approval number K243259.

What company makes MASADA Modular Spinal Fixation System?

MASADA Modular Spinal Fixation System is manufactured by Astura Medical.

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

The FDA product code for MASADA Modular 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)

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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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