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FDA 510(k)

OrthoPediatrics Wrist Fusion Plate

K-Number: K172425 · 2017-12-06

Decision Date2017-12-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics Wrist Fusion Plate is a medical device manufactured by Orthopediatrics, Inc.. It received FDA 510(k) clearance on 2017-12-06 under approval number K172425. 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 Wrist Fusion Plate?

OrthoPediatrics Wrist Fusion Plate is a medical device that received FDA 510(k) clearance on 2017-12-06. It is manufactured by Orthopediatrics, Inc.. The 510(k) number is K172425.

When was OrthoPediatrics Wrist Fusion Plate approved by the FDA?

OrthoPediatrics Wrist Fusion Plate received FDA 510(k) clearance on 2017-12-06, under approval number K172425.

What company makes OrthoPediatrics Wrist Fusion Plate?

OrthoPediatrics Wrist Fusion Plate is manufactured by Orthopediatrics, Inc..

What is the FDA product code for OrthoPediatrics Wrist Fusion Plate?

The FDA product code for OrthoPediatrics Wrist Fusion Plate is HRS.

Related Clinical Trials

Other Devices by Orthopediatrics, Inc.

Related Devices (Code: HRS)

Official Source

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