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FDA 510(k)

OrthoPediatrics Titanium PediPlates® System

K-Number: K171173 · 2017-08-24

ApplicantOrthoPediatrics Corp.
Decision Date2017-08-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics Titanium PediPlates® System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2017-08-24 under approval number K171173. 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 Titanium PediPlates® System?

OrthoPediatrics Titanium PediPlates® System is a medical device that received FDA 510(k) clearance on 2017-08-24. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K171173.

When was OrthoPediatrics Titanium PediPlates® System approved by the FDA?

OrthoPediatrics Titanium PediPlates® System received FDA 510(k) clearance on 2017-08-24, under approval number K171173.

What company makes OrthoPediatrics Titanium PediPlates® System?

OrthoPediatrics Titanium PediPlates® System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for OrthoPediatrics Titanium PediPlates® System?

The FDA product code for OrthoPediatrics Titanium PediPlates® 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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