Cleared Traditional

K031381 - UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

K031381 is an FDA 510(k) clearance for UCR SPINAL SYSTEM, manufactured by Seaspine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031381 · Seaspine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
90d
Days
Class 2
Risk

K031381 is an FDA 510(k) clearance for the UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Seaspine (San Diego, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 90 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 Seaspine devices

FDA 510(k) Submission Details - K031381

510(k) Number K031381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2003
Decision Date July 30, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 218
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K031381.
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · Medtronic Sofamor Danek · Sep 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · Medtronic Sofamor Danek · Sep 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · Ebi, L.P. · Aug 2003
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc. · Jun 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · Medtronic Sofamor Danek · Jun 2003
CD HORIZON SPINAL SYSTEM
K030932 · Medtronic Sofamor Danek, Inc. · May 2003