Cleared Traditional

K160320 - Premier

K160320 is an FDA 510(k) clearance for Premier, manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
56d
Days
Class 2
Risk

K160320 is an FDA 510(k) clearance for the Premier. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Shandong Weigao Orthopaedic Device Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on April 1, 2016 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K160320

510(k) Number K160320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K160320.
Double Medical Universal Spine System
K151458 · Double Medical Technology, Inc. · Aug 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K160124 · Spinevision S.A. · Apr 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
YAHUA Spinal System
K152324 · Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. · Feb 2016
FIREFLY Pedicle Screw Navigation Guide
K143222 · Mighty Oak Medical, Inc. · Dec 2015