Cleared Traditional

K943523 - ANTERIOR CERVIAL PLATING SYSTEM

K943523 is the FDA 510(k) clearance for ANTERIOR CERVIAL PLATING SYSTEM by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K943523 · Smith & Nephew Richards, Inc. · Orthopedic device
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Dec 1994
Decision
151d
Days
Class 2
Risk

K943523 is an FDA 510(k) clearance for the ANTERIOR CERVIAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 151 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K943523 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 21, 1994
Decision Date December 19, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K943523.
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
ISOLA ANTERIOR SYSTEM
K943819 · Acromed Corp. · Feb 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · Electro-Biology, Inc. · Feb 1995
WEBB-MORLEY SPINE SYSTEM
K941367 · Electro-Biology, Inc. · Dec 1994
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994
ANTERIOR SPINE SYSTEM
K934429 · Buckman Co., Inc. · Oct 1994