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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 the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) 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. The listed applicant is TriMed, Inc.. The 510(k) number is K261241.

When did TriMed Compression Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for TriMed Compression Screws?

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 Compression Screws?

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

Other records listing TriMed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.