Cleared Traditional

K040721 - ASSURE ANTERIOR CERVICAL PLATE SYSTEM

K040721 is an FDA 510(k) clearance for ASSURE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040721 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
90d
Days
Class 2
Risk

K040721 is an FDA 510(k) clearance for the ASSURE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on June 17, 2004 after a review of 90 days - within the typical 510(k) review window.

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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K040721

510(k) Number K040721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2004
Decision Date June 17, 2004
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 617
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K040721.
MACROPORE HYDROSORB SPINE SYSTEM
K041105 · Macropore Biosurgery, Inc. · Jul 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794 · Interpore Cross Intl. · Jul 2004
CD HORIZON SPINAL SYSTEM
K041460 · Medtronic Sofamor Danek USA, Inc. · Jul 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · Depuy Spine, Inc. · Jun 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · Medtronic Sofamor Danek, Inc. · May 2004
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
K040017 · Aesculap, Inc. · May 2004