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FDA 510(k)

JPS JuniOrtho Plating System

K-Number: K200246 · 2020-05-22

ApplicantOrthofix Srl
Decision Date2020-05-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JPS JuniOrtho Plating System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2020-05-22 under approval number K200246. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JPS JuniOrtho Plating System?

JPS JuniOrtho Plating System is a medical device that received FDA 510(k) clearance on 2020-05-22. It is manufactured by Orthofix Srl. The 510(k) number is K200246.

When was JPS JuniOrtho Plating System approved by the FDA?

JPS JuniOrtho Plating System received FDA 510(k) clearance on 2020-05-22, under approval number K200246.

What company makes JPS JuniOrtho Plating System?

JPS JuniOrtho Plating System is manufactured by Orthofix Srl.

What is the FDA product code for JPS JuniOrtho Plating System?

The FDA product code for JPS JuniOrtho Plating System is HRS.

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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