FDA 510(k)

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

Número K: K251945 · 2025-07-10

Data da decisão2025-07-10

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is TriMed, Inc.. The 510(k) number is K251945.

When did TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) receive FDA 510(k) clearance?

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

Who is the listed applicant for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

The FDA 510(k) record lists TriMed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam TriMed, Inc. como candidato(a)

K262344Large Compression Screws K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )K261241TriMed Compression Screws K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)K252061Distal Xtremities System K251134RipCord

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Fonte oficial

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