Cleared Special

K082453 - 4CIS SOLAR AND APOLLON SPINE SYSTEMS

K082453 is an FDA 510(k) clearance for 4CIS SOLAR AND APOLLON SPINE SYSTEMS, manufactured by Solco Biomedical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 29-day FDA review.

K082453 · Solco Biomedical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
29d
Days
Class 2
Risk

K082453 is an FDA 510(k) clearance for the 4CIS SOLAR AND APOLLON SPINE SYSTEMS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Solco Biomedical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on September 23, 2008 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solco Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K082453

510(k) Number K082453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2008
Decision Date September 23, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 171
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K082453.
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
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007