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FDA 510(k)

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

K-Number: K251945 · 2025-07-10

ApplicantTriMed, Inc.
Decision Date2025-07-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K251945. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by TriMed, Inc.. The 510(k) number is K251945.

When was TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) approved by the FDA?

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) received FDA 510(k) clearance on 2025-07-10, under approval number K251945.

What company makes TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

The FDA product code for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is HRS.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by TriMed, Inc.

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Related Devices (Code: HRS)

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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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