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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2022-01-18 under 510(k) 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. The listed applicant is Orthofix Srl. The 510(k) number is K213572.

When did JuniOrtho Plating System™ receive FDA 510(k) clearance?

JuniOrtho Plating System™ received FDA 510(k) clearance on 2022-01-18, under 510(k) number K213572.

Who is the listed applicant for JuniOrtho Plating System™?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Orthofix Srl as applicant

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Related Devices (Code: HWC)

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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.

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