Cleared Traditional

K082509 - EOS SPINAL SYSTEM

K082509 is an FDA 510(k) clearance for EOS SPINAL SYSTEM, manufactured by Korea Bone Bank Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K082509 · Korea Bone Bank Co., Ltd. · Orthopedic device
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Dec 2008
Decision
108d
Days
Class 2
Risk

K082509 is an FDA 510(k) clearance for the EOS SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Korea Bone Bank Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 108 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Korea Bone Bank Co., Ltd. devices

FDA 510(k) Submission Details - K082509

510(k) Number K082509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2008
Decision Date December 15, 2008
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 189
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K082509.
LANX SPINAL FIXATION SYSTEM
K083581 · Lanx, Inc. · Apr 2009
MESA SPINAL SYSTEM
K080611 · K2m, Inc. · Mar 2009
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165 · Spineart · Dec 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · Solco Biomedical Co., Ltd. · Sep 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008