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FDA 510(k)

Premier

K-Number: K160320 · 2016-04-01

ApplicantShandong Weigao Orthopaedic Device Co., Ltd.
Decision Date2016-04-01
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Premier is a medical device manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.. It received FDA 510(k) clearance on 2016-04-01 under approval number K160320. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Premier?

Premier is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K160320.

When was Premier approved by the FDA?

Premier received FDA 510(k) clearance on 2016-04-01, under approval number K160320.

What company makes Premier?

Premier is manufactured by Shandong Weigao Orthopaedic Device Co., Ltd..

What is the FDA product code for Premier?

The FDA product code for Premier is MNI.

Other Devices by Shandong Weigao Orthopaedic Device Co., Ltd.

K170861Premier

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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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