Cleared Special

K023204 - MODIFICATION TO EBI OMEGA21 SPINAL FIXA...

K023204 is the FDA 510(k) clearance for MODIFICATION TO EBI OMEGA21 SPINAL FIXA... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 23-day FDA review.

K023204 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
23d
Days
Class 2
Risk

K023204 is an FDA 510(k) clearance for the MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 23 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 Ebi, L.P. devices

Submission Details

510(k) Number K023204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2002
Decision Date October 18, 2002
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K023204.
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · Depuyacromed · Nov 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · Endius, Inc. · Jul 2002
COLORADO 2 SPINAL SYSTEM
K020247 · Medtronic Sofamor Danek, Inc. · Jul 2002
MONARCH SPINE SYSTEM
K021335 · Depuyacromed · Jul 2002