JuniOrtho Plating System
K-Number: K213572 · 2022-01-18
ApplicantOrthofix Srl
Decision Date2022-01-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
JuniOrtho Plating System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2022-01-18 under approval number K213572. 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 JuniOrtho Plating System?
JuniOrtho Plating System is a medical device that received FDA 510(k) clearance on 2022-01-18. It is manufactured by Orthofix Srl. The 510(k) number is K213572.
When was JuniOrtho Plating System approved by the FDA?
JuniOrtho Plating System received FDA 510(k) clearance on 2022-01-18, under approval number K213572.
What company makes JuniOrtho Plating System?
JuniOrtho Plating System is manufactured by Orthofix Srl.
What is the FDA product code for JuniOrtho Plating System?
The FDA product code for JuniOrtho Plating 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.