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FDA 510(k)

Patriot-SI Posterior Implant System

K-Number: K232259 · 2024-04-19

Decision Date2024-04-19
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Patriot-SI Posterior Implant System is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2024-04-19 under approval number K232259. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patriot-SI Posterior Implant System?

Patriot-SI Posterior Implant System is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K232259.

When was Patriot-SI Posterior Implant System approved by the FDA?

Patriot-SI Posterior Implant System received FDA 510(k) clearance on 2024-04-19, under approval number K232259.

What company makes Patriot-SI Posterior Implant System?

Patriot-SI Posterior Implant System is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Patriot-SI Posterior Implant System?

The FDA product code for Patriot-SI Posterior Implant System is OUR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.