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FDA 510(k)

Responsive Arthroscopy Interference Screw System

K-Number: K180573 · 2018-11-23

ApplicantResponsive Arthroscopy, LLC
Decision Date2018-11-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Responsive Arthroscopy Interference Screw System is a medical device manufactured by Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2018-11-23 under approval number K180573. 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 Responsive Arthroscopy Interference Screw System?

Responsive Arthroscopy Interference Screw System is a medical device that received FDA 510(k) clearance on 2018-11-23. It is manufactured by Responsive Arthroscopy, LLC. The 510(k) number is K180573.

When was Responsive Arthroscopy Interference Screw System approved by the FDA?

Responsive Arthroscopy Interference Screw System received FDA 510(k) clearance on 2018-11-23, under approval number K180573.

What company makes Responsive Arthroscopy Interference Screw System?

Responsive Arthroscopy Interference Screw System is manufactured by Responsive Arthroscopy, LLC.

What is the FDA product code for Responsive Arthroscopy Interference Screw System?

The FDA product code for Responsive Arthroscopy Interference Screw System is HWC. This falls under the Cardiovascular category.

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Other Devices by Responsive Arthroscopy, LLC

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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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