Nexis® compressive screws
K-Number: K223468 · 2023-08-30
ApplicantNovastep
Decision Date2023-08-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Nexis® compressive screws is a medical device manufactured by Novastep. It received FDA 510(k) clearance on 2023-08-30 under approval number K223468. 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 Nexis® compressive screws?
Nexis® compressive screws is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Novastep. The 510(k) number is K223468.
When was Nexis® compressive screws approved by the FDA?
Nexis® compressive screws received FDA 510(k) clearance on 2023-08-30, under approval number K223468.
What company makes Nexis® compressive screws?
Nexis® compressive screws is manufactured by Novastep.
What is the FDA product code for Nexis® compressive screws?
The FDA product code for Nexis® compressive 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.