Cleared Traditional

K082504 - APOLLO ANTERIOR CERVICAL PLATE SYSTEM

K082504 is an FDA 510(k) clearance for APOLLO ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Apollo Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K082504 · Apollo Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
151d
Days
Class 2
Risk

K082504 is an FDA 510(k) clearance for the APOLLO ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Apollo Spine, Inc. (Newport Beach, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Apollo Spine, Inc. devices

FDA 510(k) Submission Details - K082504

510(k) Number K082504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2008
Decision Date January 27, 2009
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 495
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K082504.
NUVASIVE HELIX-T ACP SYSTEM
K083341 · Nuvasive, Inc. · Mar 2009
PACP
K083663 · Pioneer Surgical Technology · Feb 2009
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K083338 · Seaspine, Inc. · Feb 2009
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380 · K2m, Inc. · Nov 2008
BIOMET ANTERIOR LUMBAR PLATE
K082187 · Ebi, L.P. · Nov 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070 · Nuvasive, Inc. · Sep 2008