REVCON (TM) Screw System
K-Number: K223392 · 2023-02-28
ApplicantVoom Medical Devices, Inc.
Decision Date2023-02-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
REVCON (TM) Screw System is a medical device manufactured by Voom Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-02-28 under approval number K223392. 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 REVCON (TM) Screw System?
REVCON (TM) Screw System is a medical device that received FDA 510(k) clearance on 2023-02-28. It is manufactured by Voom Medical Devices, Inc.. The 510(k) number is K223392.
When was REVCON (TM) Screw System approved by the FDA?
REVCON (TM) Screw System received FDA 510(k) clearance on 2023-02-28, under approval number K223392.
What company makes REVCON (TM) Screw System?
REVCON (TM) Screw System is manufactured by Voom Medical Devices, Inc..
What is the FDA product code for REVCON (TM) Screw System?
The FDA product code for REVCON (TM) 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.