Phantom Metatarsal Shortening System
K-Number: K223184 · 2022-12-16
ApplicantParagon 28, Inc.
Decision Date2022-12-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Phantom Metatarsal Shortening System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K223184. 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 Phantom Metatarsal Shortening System?
Phantom Metatarsal Shortening System is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Paragon 28, Inc.. The 510(k) number is K223184.
When was Phantom Metatarsal Shortening System approved by the FDA?
Phantom Metatarsal Shortening System received FDA 510(k) clearance on 2022-12-16, under approval number K223184.
What company makes Phantom Metatarsal Shortening System?
Phantom Metatarsal Shortening System is manufactured by Paragon 28, Inc..
What is the FDA product code for Phantom Metatarsal Shortening System?
The FDA product code for Phantom Metatarsal Shortening System is HWC. This falls under the Cardiovascular category.
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Official Source
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