Cleared Traditional

K161151 - Spinal fixation system

K161151 is an FDA 510(k) clearance for Spinal fixation system, manufactured by Canwell Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K161151 · Canwell Medical Co., Ltd. · Orthopedic device
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Sep 2016
Decision
149d
Days
Class 2
Risk

K161151 is an FDA 510(k) clearance for the Spinal fixation system. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Canwell Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on September 21, 2016 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Canwell Medical Co., Ltd. devices

FDA 510(k) Submission Details - K161151

510(k) Number K161151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date September 21, 2016
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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

Osmunda Medical Device Service Group
MIKE GU

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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 301
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K161151.
Reliance Spinal Screw System
K162066 · Reliance Medical Systems, LLC · Dec 2016
CastleLoc Spinal Fixation System
K162801 · L & K Biomed Co., Ltd. · Nov 2016
FixxSure® X-Link
K162143 · Innovasis, Inc. · Sep 2016
ANAX™ 5.5 Spinal System
K162189 · U&I Corporation · Aug 2016
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016