Healix Compression Screw System
K-Number: K200914 · 2020-05-05
Decision Date2020-05-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Healix Compression Screw System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-05 under approval number K200914. 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 Healix Compression Screw System?
Healix Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-05-05. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K200914.
When was Healix Compression Screw System approved by the FDA?
Healix Compression Screw System received FDA 510(k) clearance on 2020-05-05, under approval number K200914.
What company makes Healix Compression Screw System?
Healix Compression Screw System is manufactured by Nvision Biomedical Technologies, Inc..
What is the FDA product code for Healix Compression Screw System?
The FDA product code for Healix 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.