DeviceClearance

TriMed Non-Spanning Wrist Fusion Plates (4 models)— 510(k) K262032

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K262032 for TriMed Non-Spanning Wrist Fusion Plates (4 models), Substantially Equivalent on 2026-07-16. Applicant: TriMed, Inc.. Device class: 2.

Summary

TriMed's Non-Spanning Wrist Fusion Plates come in four versions (NSFL-STD, NSFR-STD, NSFL-SHB, and NSFR-SHB), filed under HRS, bone fixation plates. The record doesn't say what the suffixes mean.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

TriMed filed from Santa Clarita, California. The decision came 29 calendar days after receipt (June 17 to July 16, 2026).

Clearance details

Device name as filed
TriMed 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 )
Applicant
TriMed, Inc.
Product code
Product code HRS
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
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.