CurvaFix Intramedullary Rodscrew System
K-Number: K180050 · 2019-03-01
ApplicantCurvafix, Inc.
Decision Date2019-03-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CurvaFix Intramedullary Rodscrew System is a medical device manufactured by Curvafix, Inc.. It received FDA 510(k) clearance on 2019-03-01 under approval number K180050. 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 CurvaFix Intramedullary Rodscrew System?
CurvaFix Intramedullary Rodscrew System is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Curvafix, Inc.. The 510(k) number is K180050.
When was CurvaFix Intramedullary Rodscrew System approved by the FDA?
CurvaFix Intramedullary Rodscrew System received FDA 510(k) clearance on 2019-03-01, under approval number K180050.
What company makes CurvaFix Intramedullary Rodscrew System?
CurvaFix Intramedullary Rodscrew System is manufactured by Curvafix, Inc..
What is the FDA product code for CurvaFix Intramedullary Rodscrew System?
The FDA product code for CurvaFix Intramedullary Rodscrew System is HWC. This falls under the Cardiovascular category.
Related Clinical Trials
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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.