RetroFix
K-Number: K200226 · 2020-06-26
ApplicantRetrofix Screws, LLC
Decision Date2020-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
RetroFix is a medical device manufactured by Retrofix Screws, LLC. It received FDA 510(k) clearance on 2020-06-26 under approval number K200226. 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 RetroFix?
RetroFix is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Retrofix Screws, LLC. The 510(k) number is K200226.
When was RetroFix approved by the FDA?
RetroFix received FDA 510(k) clearance on 2020-06-26, under approval number K200226.
What company makes RetroFix?
RetroFix is manufactured by Retrofix Screws, LLC.
What is the FDA product code for RetroFix?
The FDA product code for RetroFix 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.