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FDA 510(k)

Locking Plate System

K-Number: K162380 · 2017-05-02

ApplicantBeijing Keyi Medical Device Technology Co., Ltd.
Decision Date2017-05-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Locking Plate System is a medical device manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-05-02 under approval number K162380. 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 Locking Plate System?

Locking Plate System is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K162380.

When was Locking Plate System approved by the FDA?

Locking Plate System received FDA 510(k) clearance on 2017-05-02, under approval number K162380.

What company makes Locking Plate System?

Locking Plate System is manufactured by Beijing Keyi Medical Device Technology Co., Ltd..

What is the FDA product code for Locking Plate System?

The FDA product code for Locking Plate System is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Beijing Keyi Medical Device Technology Co., Ltd.

K190567KeYi Spinal Fixation System K191826KeYi Total Hip System K230120KeYi Total Knee System

Related Devices (Code: 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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