Cannulated Screws
K-Number: K213614 · 2022-08-03
ApplicantMaxxion Medical, LLC
Decision Date2022-08-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cannulated Screws is a medical device manufactured by Maxxion Medical, LLC. It received FDA 510(k) clearance on 2022-08-03 under approval number K213614. 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 Cannulated Screws?
Cannulated Screws is a medical device that received FDA 510(k) clearance on 2022-08-03. It is manufactured by Maxxion Medical, LLC. The 510(k) number is K213614.
When was Cannulated Screws approved by the FDA?
Cannulated Screws received FDA 510(k) clearance on 2022-08-03, under approval number K213614.
What company makes Cannulated Screws?
Cannulated Screws is manufactured by Maxxion Medical, LLC.
What is the FDA product code for Cannulated Screws?
The FDA product code for Cannulated 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.