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FDA 510(k)

Paratrooper Plantar Plate Repair System

K-Number: K191227 · 2020-01-24

ApplicantParagon 28, Inc.
Decision Date2020-01-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paratrooper Plantar Plate Repair System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-01-24 under approval number K191227. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paratrooper Plantar Plate Repair System?

Paratrooper Plantar Plate Repair System is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by Paragon 28, Inc.. The 510(k) number is K191227.

When was Paratrooper Plantar Plate Repair System approved by the FDA?

Paratrooper Plantar Plate Repair System received FDA 510(k) clearance on 2020-01-24, under approval number K191227.

What company makes Paratrooper Plantar Plate Repair System?

Paratrooper Plantar Plate Repair System is manufactured by Paragon 28, Inc..

What is the FDA product code for Paratrooper Plantar Plate Repair System?

The FDA product code for Paratrooper Plantar Plate Repair System is MBI.

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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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