Cannulated Screw System
K-Number: K233396 · 2023-12-21
ApplicantSmith & Nephew, Inc.
Decision Date2023-12-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cannulated Screw System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2023-12-21 under approval number K233396. 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 Screw System?
Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K233396.
When was Cannulated Screw System approved by the FDA?
Cannulated Screw System received FDA 510(k) clearance on 2023-12-21, under approval number K233396.
What company makes Cannulated Screw System?
Cannulated Screw System is manufactured by Smith & Nephew, Inc..
What is the FDA product code for Cannulated Screw System?
The FDA product code for Cannulated Screw System 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.