Cleared Special

K083826 - LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM

K083826 is an FDA 510(k) clearance for LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM, manufactured by Allez Spine, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K083826 · Allez Spine, LLC · Orthopedic device
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Jan 2009
Decision
30d
Days
Class 2
Risk

K083826 is an FDA 510(k) clearance for the LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Allez Spine, LLC (Irvine, US). The FDA issued a Cleared decision on January 22, 2009 after a review of 30 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 Allez Spine, LLC devices

FDA 510(k) Submission Details - K083826

510(k) Number K083826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2008
Decision Date January 22, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 201
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K083826.
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
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