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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 the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Orthopaedic Device Co., Ltd.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) 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. The listed applicant is Shandong Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K160320.

When did Premier receive FDA 510(k) clearance?

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

Who is the listed applicant for Premier?

The FDA 510(k) record lists Shandong Weigao Orthopaedic Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premier?

The FDA product code for Premier is MNI.

Other records listing Shandong Weigao Orthopaedic Device Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170861Premier

Related Devices (Code: MNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160003Sniper (R) Spine SystemSpine Wave, Inc.

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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