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FDA 510(k)

Premier

K-Number: K170861 · 2017-08-04

ApplicantShandong Weigao Orthopaedic Device Co., Ltd.
Decision Date2017-08-04
Product CodeNKB
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 2017-08-04 under approval number K170861. The device is classified under product code NKB. 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 2017-08-04. It is manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K170861.

When was Premier approved by the FDA?

Premier received FDA 510(k) clearance on 2017-08-04, under approval number K170861.

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 NKB.

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

K160320Premier

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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