TDM Screw Systems
K-Number: K190830 · 2019-09-13
ApplicantTdm Co., Ltd.
Decision Date2019-09-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TDM Screw Systems is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2019-09-13 under approval number K190830. 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 Systems?
TDM Screw Systems is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K190830.
When was TDM Screw Systems approved by the FDA?
TDM Screw Systems received FDA 510(k) clearance on 2019-09-13, under approval number K190830.
What company makes TDM Screw Systems?
TDM Screw Systems is manufactured by Tdm Co., Ltd..
What is the FDA product code for TDM Screw Systems?
The FDA product code for TDM Screw Systems is HWC. This falls under the Cardiovascular category.
Related Clinical Trials
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Official Source
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