Cleared Traditional

K080876 - DVX SPINE SYSTEM

K080876 is an FDA 510(k) clearance for DVX SPINE SYSTEM, manufactured by Bk Meditech, Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K080876 · Bk Meditech, Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
65d
Days
Class 2
Risk

K080876 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 June 4, 2008 after a review of 65 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.

FDA 510(k) Submission Details - K080876

510(k) Number K080876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date June 04, 2008
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K080876.
GPS, G SURGICAL PEDICLE SYSTEM
K081041 · G Surgical Co., Ltd. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
PREFERENCE PEDICLE SCREW SYSTEM
K081296 · Us Spine · Jun 2008
ACCIN PEDICLE SCREW SYSTEM
K073531 · Accelerated Innovation, LLC · Feb 2008
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070530 · Medicrea Technologies · Oct 2007
K080876 · DVX SPINE SYSTEM
Download PDF FDA Summary Bk Meditech, Co., Ltd.