Cleared Traditional

K002592 - INTERPORE CROSS ANTERIOR CERVICAL PLATE...

K002592 is the FDA 510(k) clearance for INTERPORE CROSS ANTERIOR CERVICAL PLATE... by Interpore Cross Intl.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K002592 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
46d
Days
Class 2
Risk

K002592 is an FDA 510(k) clearance for the INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on October 6, 2000 after a review of 46 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interpore Cross Intl. devices

Submission Details

510(k) Number K002592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date October 06, 2000
Days to Decision 46 days
Submission Type Traditional
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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K002592.
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · Ebi, L.P. · Jan 2001
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · Ebi, L.P. · Oct 2000
XIA SPINE SYSTEM
K002858 · Howmedica Osteonics Corp. · Oct 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K002371 · Spineology, Inc. · Sep 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · Encore Orthopedics, Inc. · Aug 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · Ebi, L.P. · Jul 2000