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FDA 510(k)

Advanced Research Medical Trident SI Screw System

K-Number: K203373 · 2021-01-22

ApplicantAdvanced Research Medical, LLC
Decision Date2021-01-22
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Advanced Research Medical Trident SI Screw System is a medical device manufactured by Advanced Research Medical, LLC. It received FDA 510(k) clearance on 2021-01-22 under approval number K203373. 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 Advanced Research Medical Trident SI Screw System?

Advanced Research Medical Trident SI Screw System is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Advanced Research Medical, LLC. The 510(k) number is K203373.

When was Advanced Research Medical Trident SI Screw System approved by the FDA?

Advanced Research Medical Trident SI Screw System received FDA 510(k) clearance on 2021-01-22, under approval number K203373.

What company makes Advanced Research Medical Trident SI Screw System?

Advanced Research Medical Trident SI Screw System is manufactured by Advanced Research Medical, LLC.

What is the FDA product code for Advanced Research Medical Trident SI Screw System?

The FDA product code for Advanced Research Medical Trident SI Screw System is OUR.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Advanced Research Medical, LLC

K173947Lumbar Interbody Fusion System (OLLIF)

Related Devices (Code: OUR)

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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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