Cleared Traditional

K151362 - HC Spinal System

K151362 is an FDA 510(k) clearance for HC Spinal System, manufactured by Hung Chun Bio-S Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K151362 · Hung Chun Bio-S Co., Ltd. · Orthopedic device
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May 2016
Decision
350d
Days
Class 2
Risk

K151362 is an FDA 510(k) clearance for the HC Spinal System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Hung Chun Bio-S Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on May 5, 2016 after a review of 350 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Hung Chun Bio-S Co., Ltd. devices

FDA 510(k) Submission Details - K151362

510(k) Number K151362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2015
Decision Date May 05, 2016
Days to Decision 350 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
228d slower than avg
Panel avg: 122d · This submission: 350d
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

Acmebiotechs Consulting Incorporation
MICHAEL LEE

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 294
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K151362.
FixxSure® X-Link
K162143 · Innovasis, Inc. · Sep 2016
Spinal fixation system
K161151 · Canwell Medical Co., Ltd. · Sep 2016
ANAX™ 5.5 Spinal System
K162189 · U&I Corporation · Aug 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020 · Captiva Spine · Mar 2016
Spinal Inner Fixation System
K143013 · Changzhou Dingjian Medical Appliance Co., Ltd. · Dec 2015