TriMed Threaded Intramedullary Nail System
K-Number: K230749 · 2023-04-17
ApplicantTriMed, Inc.
Decision Date2023-04-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TriMed Threaded Intramedullary Nail System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2023-04-17 under approval number K230749. 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 Threaded Intramedullary Nail System?
TriMed Threaded Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2023-04-17. It is manufactured by TriMed, Inc.. The 510(k) number is K230749.
When was TriMed Threaded Intramedullary Nail System approved by the FDA?
TriMed Threaded Intramedullary Nail System received FDA 510(k) clearance on 2023-04-17, under approval number K230749.
What company makes TriMed Threaded Intramedullary Nail System?
TriMed Threaded Intramedullary Nail System is manufactured by TriMed, Inc..
What is the FDA product code for TriMed Threaded Intramedullary Nail System?
The FDA product code for TriMed Threaded Intramedullary Nail System is HWC. This falls under the Cardiovascular category.
Related Clinical Trials
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Official Source
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