Cleared Traditional

K934756 - CODMAN ANTERIOR CERVICAL SPINE PLATE SY...

K934756 is the FDA 510(k) clearance for CODMAN ANTERIOR CERVICAL SPINE PLATE SY... by Codman & Shurtleff, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K934756 · Codman & Shurtleff, Inc. · Orthopedic device
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Nov 1994
Decision
399d
Days
Class 2
Risk

K934756 is an FDA 510(k) clearance for the CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on November 8, 1994 after a review of 399 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K934756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date November 08, 1994
Days to Decision 399 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
277d slower than avg
Panel avg: 122d · This submission: 399d
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 344
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K934756.
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · Smith & Nephew Richards, Inc. · Dec 1994
ANTERIOR SPINE SYSTEM
K934429 · Buckman Co., Inc. · Oct 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · Aesculap, Inc. · Aug 1994
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE
K925351 · Synthes (Usa) · Nov 1993