Cleared Special

K000513 - MODIFICATION TO EBI SPINELINK ANTERIOR ...

K000513 is the FDA 510(k) clearance for MODIFICATION TO EBI SPINELINK ANTERIOR ... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 20-day FDA review.

K000513 · Ebi, L.P. · Orthopedic device
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Mar 2000
Decision
20d
Days
Class 2
Risk

K000513 is an FDA 510(k) clearance for the MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL 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 March 7, 2000 after a review of 20 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 K000513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2000
Decision Date March 07, 2000
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 K000513.
CENTAUR SPINAL SYSTEM
K994347 · Howmedica Osteonics Corp. · Mar 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · United States Surgical, A Division of Tyco Healthc · Mar 2000
ROD TO ROD CROSS BRACES
K000634 · Corin USA · Mar 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · Danek Medical, Inc. · Feb 2000
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999