TriMed® Compression Screws
K-Number: K243943 · 2025-04-10
ApplicantTriMed, Inc.
Decision Date2025-04-10
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 2025-04-10 under approval number K243943. 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 2025-04-10. It is manufactured by TriMed, Inc.. The 510(k) number is K243943.
When was TriMed® Compression Screws approved by the FDA?
TriMed® Compression Screws received FDA 510(k) clearance on 2025-04-10, under approval number K243943.
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 Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.