Cleared Traditional

K033951 - RADIX CERVICAL PLATE

K033951 is an FDA 510(k) clearance for RADIX CERVICAL PLATE, manufactured by Pisharodi Surgicals, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K033951 · Pisharodi Surgicals, Inc. · Orthopedic device
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Jul 2004
Decision
192d
Days
Class 2
Risk

K033951 is an FDA 510(k) clearance for the RADIX CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Pisharodi Surgicals, Inc. (Round Rock, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 192 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 Pisharodi Surgicals, Inc. devices

FDA 510(k) Submission Details - K033951

510(k) Number K033951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date July 01, 2004
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 516
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K033951.
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004
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
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · Globus Medical, Inc. · Jun 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · Depuy Spine, Inc. · Jun 2004