Hand Trauma Screw System
K-Number: K220723 · 2022-05-12
ApplicantSkeletal Dynamics, Inc.
Decision Date2022-05-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Hand Trauma Screw System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2022-05-12 under approval number K220723. 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 Hand Trauma Screw System?
Hand Trauma Screw System is a medical device that received FDA 510(k) clearance on 2022-05-12. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K220723.
When was Hand Trauma Screw System approved by the FDA?
Hand Trauma Screw System received FDA 510(k) clearance on 2022-05-12, under approval number K220723.
What company makes Hand Trauma Screw System?
Hand Trauma Screw System is manufactured by Skeletal Dynamics, Inc..
What is the FDA product code for Hand Trauma Screw System?
The FDA product code for Hand Trauma 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.