Cleared Special

K080828 - MOUNTAINEER OCT SPINAL SYSTEM

K080828 is an FDA 510(k) clearance for MOUNTAINEER OCT SPINAL SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 94-day FDA review.

K080828 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
94d
Days
Class 2
Risk

K080828 is an FDA 510(k) clearance for the MOUNTAINEER OCT SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 94 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080828

510(k) Number K080828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2008
Decision Date June 27, 2008
Days to Decision 94 days
Submission Type Special
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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K080828.
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · Solco Biomedical Co., Ltd. · Sep 2008
FIXXSURE CROSS LINK
K081331 · Spineworks, LLC · Jul 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631 · Sintea Biotech, Inc. · Jul 2008
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
K080828 · MOUNTAINEER OCT SPINAL SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.