Monster® Screw System
K-Number: K190586 · 2019-04-03
ApplicantParagon 28, Inc.
Decision Date2019-04-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Monster® Screw System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2019-04-03 under approval number K190586. 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 Monster® Screw System?
Monster® Screw System is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Paragon 28, Inc.. The 510(k) number is K190586.
When was Monster® Screw System approved by the FDA?
Monster® Screw System received FDA 510(k) clearance on 2019-04-03, under approval number K190586.
What company makes Monster® Screw System?
Monster® Screw System is manufactured by Paragon 28, Inc..
What is the FDA product code for Monster® Screw System?
The FDA product code for Monster® 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.