Cleared Special

K003764 - MODIFICATION TO EBI SPINELINK SYSTEM

K003764 is the FDA 510(k) clearance for MODIFICATION TO EBI SPINELINK SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K003764 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2001
Decision
27d
Days
Class 2
Risk

K003764 is an FDA 510(k) clearance for the MODIFICATION TO EBI SPINELINK 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 January 2, 2001 after a review of 27 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 K003764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 02, 2001
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K003764.
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K010776 · Corin USA · Apr 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · Endius, Inc. · Mar 2001
CD HORIZON SPINAL SYSTEM
K010249 · Medtronic Sofamor Danek, Inc. · Feb 2001
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc. · Dec 2000
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · Medtronic Sofamor Danek, Inc. · Sep 2000