Metal Cannulated Screw
K-Number: K221090 · 2023-01-10
ApplicantDouble Medical Technology, Inc.
Decision Date2023-01-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Metal Cannulated Screw is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-10 under approval number K221090. 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 Metal Cannulated Screw?
Metal Cannulated Screw is a medical device that received FDA 510(k) clearance on 2023-01-10. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K221090.
When was Metal Cannulated Screw approved by the FDA?
Metal Cannulated Screw received FDA 510(k) clearance on 2023-01-10, under approval number K221090.
What company makes Metal Cannulated Screw?
Metal Cannulated Screw is manufactured by Double Medical Technology, Inc..
What is the FDA product code for Metal Cannulated Screw?
The FDA product code for Metal Cannulated Screw 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.