Cleared Traditional

K081883 - MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM

K081883 is an FDA 510(k) clearance for MODIFICATION TO PREFERENCE PEDICLE SCRE..., manufactured by Us Spine. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K081883 · Us Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
84d
Days
Class 2
Risk

K081883 is an FDA 510(k) clearance for the MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Us Spine (Apple Valley, US). The FDA issued a Cleared decision on September 24, 2008 after a review of 84 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 - K081883

510(k) Number K081883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date September 24, 2008
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K081883.
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FIXXSURE CROSS LINK
K081331 · Spineworks, LLC · Jul 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631 · Sintea Biotech, Inc. · Jul 2008
K081883 · MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
Download PDF FDA Summary Us Spine