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FDA 510(k)

OrthoPediatrics Locking Proximal Femur System Cortical Screws

K-Number: K162307 · 2016-09-27

ApplicantOrthoPediatrics Corp.
Decision Date2016-09-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics Locking Proximal Femur System Cortical Screws is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2016-09-27 under approval number K162307. 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 Locking Proximal Femur System Cortical Screws?

OrthoPediatrics Locking Proximal Femur System Cortical Screws is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K162307.

When was OrthoPediatrics Locking Proximal Femur System Cortical Screws approved by the FDA?

OrthoPediatrics Locking Proximal Femur System Cortical Screws received FDA 510(k) clearance on 2016-09-27, under approval number K162307.

What company makes OrthoPediatrics Locking Proximal Femur System Cortical Screws?

OrthoPediatrics Locking Proximal Femur System Cortical Screws is manufactured by OrthoPediatrics Corp..

What is the FDA product code for OrthoPediatrics Locking Proximal Femur System Cortical Screws?

The FDA product code for OrthoPediatrics Locking Proximal Femur System Cortical Screws 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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