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FDA 510(k)

OrthoPediatrics PediNail Intramedullary Platform

K-Number: K172583 · 2018-05-10

ApplicantOrthopediatrics, Inc.
Decision Date2018-05-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics PediNail Intramedullary Platform is a medical device manufactured by Orthopediatrics, Inc.. It received FDA 510(k) clearance on 2018-05-10 under approval number K172583. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoPediatrics PediNail Intramedullary Platform?

OrthoPediatrics PediNail Intramedullary Platform is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Orthopediatrics, Inc.. The 510(k) number is K172583.

When was OrthoPediatrics PediNail Intramedullary Platform approved by the FDA?

OrthoPediatrics PediNail Intramedullary Platform received FDA 510(k) clearance on 2018-05-10, under approval number K172583.

What company makes OrthoPediatrics PediNail Intramedullary Platform?

OrthoPediatrics PediNail Intramedullary Platform is manufactured by Orthopediatrics, Inc..

What is the FDA product code for OrthoPediatrics PediNail Intramedullary Platform?

The FDA product code for OrthoPediatrics PediNail Intramedullary Platform is HSB.

Other Devices by Orthopediatrics, Inc.

K172425OrthoPediatrics Wrist Fusion Plate

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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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