Cleared Traditional

K031354 - EBI OMEGA21 SPINAL FIXATION SYSTEM

K031354 is the FDA 510(k) clearance for EBI OMEGA21 SPINAL FIXATION SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K031354 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
99d
Days
Class 2
Risk

K031354 is an FDA 510(k) clearance for the EBI OMEGA21 SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 6, 2003 after a review of 99 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 Ebi, L.P. devices

Submission Details

510(k) Number K031354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date August 06, 2003
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K031354.
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · Spinal Concepts, Inc. · Sep 2003
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
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