Cleared Traditional

K941367 - WEBB-MORLEY SPINE SYSTEM

K941367 is an FDA 510(k) clearance for WEBB-MORLEY SPINE SYSTEM, manufactured by Electro-Biology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K941367 · Electro-Biology, Inc. · Orthopedic device
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Dec 1994
Decision
259d
Days
Class 2
Risk

K941367 is an FDA 510(k) clearance for the WEBB-MORLEY SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Parsippany, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 259 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 Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K941367

510(k) Number K941367 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 21, 1994
Decision Date December 05, 1994
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K941367.
ISOLA ANTERIOR SYSTEM
K943819 · Acromed Corp. · Feb 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · Electro-Biology, Inc. · Feb 1995
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · Smith & Nephew Richards, Inc. · Dec 1994
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994
ANTERIOR SPINE SYSTEM
K934429 · Buckman Co., Inc. · Oct 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · Aesculap, Inc. · Aug 1994