Arthrex Compression FT Screws
K-Number: K182361 · 2018-12-18
ApplicantArthrex, Inc.
Decision Date2018-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex Compression FT Screws is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-12-18 under approval number K182361. 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 Compression FT Screws?
Arthrex Compression FT Screws is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Arthrex, Inc.. The 510(k) number is K182361.
When was Arthrex Compression FT Screws approved by the FDA?
Arthrex Compression FT Screws received FDA 510(k) clearance on 2018-12-18, under approval number K182361.
What company makes Arthrex Compression FT Screws?
Arthrex Compression FT Screws is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex Compression FT Screws?
The FDA product code for Arthrex Compression 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.