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FDA 510(k)

OrthoPediatrics PediFoot Deformity Corrections System

K-Number: K190992 · 2019-08-06

ApplicantOrthoPediatrics Corp.
Decision Date2019-08-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics PediFoot Deformity Corrections System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-08-06 under approval number K190992. 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 OrthoPediatrics PediFoot Deformity Corrections System?

OrthoPediatrics PediFoot Deformity Corrections System is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K190992.

When was OrthoPediatrics PediFoot Deformity Corrections System approved by the FDA?

OrthoPediatrics PediFoot Deformity Corrections System received FDA 510(k) clearance on 2019-08-06, under approval number K190992.

What company makes OrthoPediatrics PediFoot Deformity Corrections System?

OrthoPediatrics PediFoot Deformity Corrections System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for OrthoPediatrics PediFoot Deformity Corrections System?

The FDA product code for OrthoPediatrics PediFoot Deformity Corrections System is HRS.

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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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