Cleared Traditional

Premier

K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Orthopedic

Apr 2016

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K160320 is an FDA 510(k) clearance for the Premier, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Shandong Weigao Orthopaedic Device Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on April 1, 2016, 56 days after receiving the submission on February 5, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K160320 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2016
Decision Date	April 01, 2016
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF