Arthrex Beveled FT Screws
K-Number: K210994 · 2021-06-01
ApplicantArthrex, Inc.
Decision Date2021-06-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex Beveled FT Screws is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-06-01 under approval number K210994. 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 Beveled FT Screws?
Arthrex Beveled FT Screws is a medical device that received FDA 510(k) clearance on 2021-06-01. It is manufactured by Arthrex, Inc.. The 510(k) number is K210994.
When was Arthrex Beveled FT Screws approved by the FDA?
Arthrex Beveled FT Screws received FDA 510(k) clearance on 2021-06-01, under approval number K210994.
What company makes Arthrex Beveled FT Screws?
Arthrex Beveled FT Screws is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex Beveled FT Screws?
The FDA product code for Arthrex Beveled FT 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.