Cleared Abbreviated

K002371 - K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

K002371 is an FDA 510(k) clearance for K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Abbreviated 510(k) pathway after a 50-day FDA review.

K002371 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
50d
Days
Class 2
Risk

K002371 is an FDA 510(k) clearance for the K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 15, 2000 after a review of 50 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spineology, Inc. devices

FDA 510(k) Submission Details - K002371

510(k) Number K002371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2000
Decision Date September 15, 2000
Days to Decision 50 days
Submission Type Abbreviated
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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Standards-based clearance path.

KWQ Device Classification - Class 2, Special Controls

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K002371.
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · Ebi, L.P. · Oct 2000
XIA SPINE SYSTEM
K002858 · Howmedica Osteonics Corp. · Oct 2000
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
K002592 · Interpore Cross Intl. · Oct 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · Encore Orthopedics, Inc. · Aug 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · Ebi, L.P. · Jul 2000
SYNTHES CERVIFIX SYSTEM
K001864 · Synthes Spine · Jul 2000