Cleared Traditional

K090424 - DVX SPINE SYSTEM

K090424 is the FDA 510(k) clearance for DVX SPINE SYSTEM by Bk Meditech, Co., Ltd.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K090424 · Bk Meditech, Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
84d
Days
Class 2
Risk

K090424 is an FDA 510(k) clearance for the DVX SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Bk Meditech, Co., Ltd. (Stillwater, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 84 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.

View all Bk Meditech, Co., Ltd. devices

Submission Details

510(k) Number K090424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date May 14, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 118
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K090424.
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · Stryker Spine · Mar 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
MESA SPINAL SYSTEM
K080611 · K2m, Inc. · Mar 2009
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165 · Spineart · Dec 2008