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FDA 510(k)

RIVAL View Plating Systems and Reduce Fracture Plating Systems

K-Number: K190388 · 2019-06-07

ApplicantOrthofix Srl
Decision Date2019-06-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIVAL View Plating Systems and Reduce Fracture Plating Systems is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2019-06-07 under approval number K190388. 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 RIVAL View Plating Systems and Reduce Fracture Plating Systems?

RIVAL View Plating Systems and Reduce Fracture Plating Systems is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Orthofix Srl. The 510(k) number is K190388.

When was RIVAL View Plating Systems and Reduce Fracture Plating Systems approved by the FDA?

RIVAL View Plating Systems and Reduce Fracture Plating Systems received FDA 510(k) clearance on 2019-06-07, under approval number K190388.

What company makes RIVAL View Plating Systems and Reduce Fracture Plating Systems?

RIVAL View Plating Systems and Reduce Fracture Plating Systems is manufactured by Orthofix Srl.

What is the FDA product code for RIVAL View Plating Systems and Reduce Fracture Plating Systems?

The FDA product code for RIVAL View Plating Systems and Reduce Fracture Plating Systems 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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