Cleared Traditional

K953730 - CODMAN ANTERIOR CERVICAL PLATE SYSTEM

K953730 is the FDA 510(k) clearance for CODMAN ANTERIOR CERVICAL PLATE SYSTEM by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953730 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Nov 1995
Decision
91d
Days
Class 2
Risk

K953730 is an FDA 510(k) clearance for the CODMAN ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raritan, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 91 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K953730 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 10, 1995
Decision Date November 09, 1995
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 445
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K953730.
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · Depuy, Inc. · Dec 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · Sofamor Danek USA,Inc. · Nov 1996
EBI ANTERIOR CERVICAL SPINE SYSTEM
K955730 · Electro-Biology, Inc. · Mar 1996
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725 · Synthes Spine · Aug 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995