Cleared Traditional

K143013 - Spinal Inner Fixation System

K143013 is an FDA 510(k) clearance for Spinal Inner Fixation System, manufactured by Changzhou Dingjian Medical Appliance Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K143013 · Changzhou Dingjian Medical Appliance Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
417d
Days
Class 2
Risk

K143013 is an FDA 510(k) clearance for the Spinal Inner Fixation System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Changzhou Dingjian Medical Appliance Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 11, 2015 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

FDA 510(k) Submission Details - K143013

510(k) Number K143013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date December 11, 2015
Days to Decision 417 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
295d slower than avg
Panel avg: 122d · This submission: 417d
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 Consulting Co., Ltd.
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 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K143013.
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020 · Captiva Spine · Mar 2016
Romeo posterior osteosynthesis system
K151695 · Spineart · Sep 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116 · Captiva Spine · Jun 2015
Republic Spine Dark Star Spinal System
K150283 · Republic Spine, LLC · Apr 2015