TDM Screw System
K-Number: K231860 · 2024-01-18
ApplicantTdm Co., Ltd.
Decision Date2024-01-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TDM Screw System is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-01-18 under approval number K231860. 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 TDM Screw System?
TDM Screw System is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K231860.
When was TDM Screw System approved by the FDA?
TDM Screw System received FDA 510(k) clearance on 2024-01-18, under approval number K231860.
What company makes TDM Screw System?
TDM Screw System is manufactured by Tdm Co., Ltd..
What is the FDA product code for TDM Screw System?
The FDA product code for TDM Screw System is HWC. This falls under the Cardiovascular category.
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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.