Cleared Traditional

K023377 - ORIA CERVICAL PLATES

K023377 is an FDA 510(k) clearance for ORIA CERVICAL PLATES, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K023377 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
147d
Days
Class 2
Risk

K023377 is an FDA 510(k) clearance for the ORIA CERVICAL PLATES. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Ortho Tec, LLC (California, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 147 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 Ortho Tec, LLC devices

FDA 510(k) Submission Details - K023377

510(k) Number K023377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date March 04, 2003
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 489
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K023377.
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · Synthes (Usa) · Apr 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · Blackstone Medical, Inc. · Mar 2003
ORIA ZENITH
K030500 · Ortho Tec, LLC · Mar 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · Medtronic Sofamor Danek · Feb 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · Spinal Concepts, Inc. · Jan 2003
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · Depuyacromed · Dec 2002