Cleared Traditional

K072436 - MEGA SPINE SYSTEM

K072436 is the FDA 510(k) clearance for MEGA SPINE SYSTEM by Bk Meditech, Co., Ltd.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K072436 · Bk Meditech, Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
63d
Days
Class 2
Risk

K072436 is an FDA 510(k) clearance for the MEGA SPINE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Bk Meditech, Co., Ltd. (Laguna Hills, US). The FDA issued a Cleared decision on November 1, 2007 after a review of 63 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 K072436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2007
Decision Date November 01, 2007
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MNI Orthosis, Spinal Pedicle Fixation

All 119
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K072436.
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QUANTUM-MIS CANNULATED SYSTEM
K080026 · Pioneer Surgical Technology · Jan 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914 · K2m, Inc. · Jan 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007