IRENE Cannulated Screw System
K-Number: K170056 · 2017-10-23
Decision Date2017-10-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
IRENE Cannulated Screw System is a medical device manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-10-23 under approval number K170056. 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 IRENE Cannulated Screw System?
IRENE Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K170056.
When was IRENE Cannulated Screw System approved by the FDA?
IRENE Cannulated Screw System received FDA 510(k) clearance on 2017-10-23, under approval number K170056.
What company makes IRENE Cannulated Screw System?
IRENE Cannulated Screw System is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd..
What is the FDA product code for IRENE Cannulated Screw System?
The FDA product code for IRENE Cannulated Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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