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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) 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. The listed applicant is Paragon 28, Inc.. The 510(k) number is K190586.

When did Monster® Screw System receive FDA 510(k) clearance?

Monster® Screw System received FDA 510(k) clearance on 2019-04-03, under 510(k) number K190586.

Who is the listed applicant for Monster® Screw System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Paragon 28, Inc. as applicant

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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