Tandry Compression Screw System
K-Number: K220359 · 2022-09-20
ApplicantMicroware Precision Co., Ltd.
Decision Date2022-09-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tandry Compression Screw System is a medical device manufactured by Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under approval number K220359. 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 Tandry Compression Screw System?
Tandry Compression Screw System is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by Microware Precision Co., Ltd.. The 510(k) number is K220359.
When was Tandry Compression Screw System approved by the FDA?
Tandry Compression Screw System received FDA 510(k) clearance on 2022-09-20, under approval number K220359.
What company makes Tandry Compression Screw System?
Tandry Compression Screw System is manufactured by Microware Precision Co., Ltd..
What is the FDA product code for Tandry Compression Screw System?
The FDA product code for Tandry Compression 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.