DeviceClearance

TriMed Compression Screws— 510(k) K261241

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K261241 for TriMed Compression Screws, Substantially Equivalent on 2026-05-14. Applicant: TriMed, Inc.. Device class: 2.

Summary

TriMed's TriMed Compression Screws are filed under HWC, bone fixation screws.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and the submission was a Special 510(k).

TriMed filed from Santa Clarita, California. The decision came 29 calendar days after receipt (April 15 to May 14, 2026).

Clearance details

Applicant
TriMed, Inc.
Product code
Product code HWC
Device class
Class 2
Regulation
21 CFR 888.3040
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 HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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.