Cleared Traditional

K923242 - CROSSLINK AXIAL AND OFFSET PLATES

K923242 is an FDA 510(k) clearance for CROSSLINK AXIAL AND OFFSET PLATES, 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 321-day FDA review.

K923242 · Sofamor Danek Mfg., Inc. · Orthopedic device
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May 1993
Decision
321d
Days
Class 2
Risk

K923242 is an FDA 510(k) clearance for the CROSSLINK AXIAL AND OFFSET PLATES. 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 May 19, 1993 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K923242

510(k) Number K923242 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 02, 1992
Decision Date May 19, 1993
Days to Decision 321 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 122d · This submission: 321d
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 472
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K923242.
SENTRY ANTERIOR SPINAL SYSTEM
K930807 · Sofamor Danek Mfg., Inc. · Oct 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · Synthes (Usa) · Jun 1993
KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV
K923703 · Acromed Corp. · 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