Cleared Special

K023133 - MODIFICATION TO EBI VUELOCK ANTERIOR CE...

K023133 is the FDA 510(k) clearance for MODIFICATION TO EBI VUELOCK ANTERIOR CE... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K023133 · Ebi, L.P. · Orthopedic device
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Oct 2002
Decision
28d
Days
Class 2
Risk

K023133 is an FDA 510(k) clearance for the MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), 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 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K023133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date October 18, 2002
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K023133.
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
K022798 · Corin USA · Nov 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · Synthes (Usa) · Nov 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · Spinal Concepts, Inc. · Oct 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · Medtronic Sofamor Danek · Sep 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · Blackstone Medical, Inc. · Aug 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · Ebi, L.P. · Aug 2002