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FDA 510(k)

TriMed Compression Screws

K-Number: K261241 · 2026-05-14

ApplicantTriMed, Inc.
Decision Date2026-05-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Compression Screws is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2026-05-14 under approval number K261241. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriMed Compression Screws?

TriMed Compression Screws is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by TriMed, Inc.. The 510(k) number is K261241.

When was TriMed Compression Screws approved by the FDA?

TriMed Compression Screws received FDA 510(k) clearance on 2026-05-14, under approval number K261241.

What company makes TriMed Compression Screws?

TriMed Compression Screws is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Compression Screws?

The FDA product code for TriMed Compression Screws is HWC. This falls under the Cardiovascular category.

Related Devices (Code: HWC)

Official Source

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