Arthrex Low Profile Screws
K-Number: K190921 · 2019-10-30
ApplicantArthrex, Inc.
Decision Date2019-10-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex Low Profile Screws is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-10-30 under approval number K190921. 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 Arthrex Low Profile Screws?
Arthrex Low Profile Screws is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Arthrex, Inc.. The 510(k) number is K190921.
When was Arthrex Low Profile Screws approved by the FDA?
Arthrex Low Profile Screws received FDA 510(k) clearance on 2019-10-30, under approval number K190921.
What company makes Arthrex Low Profile Screws?
Arthrex Low Profile Screws is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex Low Profile Screws?
The FDA product code for Arthrex Low Profile Screws 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.