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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2019-06-07 under 510(k) 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. The listed applicant is Orthofix Srl. The 510(k) number is K190388.

When did RIVAL View Plating Systems and Reduce Fracture Plating Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for RIVAL View Plating Systems and Reduce Fracture Plating Systems?

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 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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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