DeviceClearance

TriMed Wrist Fixation System (10 models)— 510(k) K243569

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K243569 for TriMed Wrist Fixation System (10 models), Substantially Equivalent on 2025-01-15. Applicant: TriMed, Inc.. Device class: 2.

Clearance details

Device name as filed
TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);
Applicant
TriMed, Inc.
Product code
Code HRS
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clarita, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HRS

product code HRS
Death
27
Injury
10,340
Malfunction
3,328
Total
13,695

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.