Cleared Traditional

K923446 - STERILE DYNA LOK ANTERIOR PLATING SYSTEM

K923446 is an FDA 510(k) clearance for STERILE DYNA LOK ANTERIOR PLATING SYSTEM, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K923446 · Sofamor Danek Mfg., Inc. · Orthopedic device
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Dec 1992
Decision
156d
Days
Class 2
Risk

K923446 is an FDA 510(k) clearance for the STERILE DYNA LOK ANTERIOR PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 156 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K923446

510(k) Number K923446 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 14, 1992
Decision Date December 17, 1992
Days to Decision 156 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 122d · This submission: 156d
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 474
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K923446.
KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV
K923703 · Acromed Corp. · May 1993
Z-PLATE ANTERIOR FIXATION SYSTEM
K922543 · Sofamor Danek Mfg., Inc. · May 1993
CROSSLINK AXIAL AND OFFSET PLATES
K923242 · Sofamor Danek Mfg., Inc. · May 1993
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · Kirschner Medical Corp. · Jan 1992
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991