Cleared Traditional

K914362 - TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS

K914362 is an FDA 510(k) clearance for TOP CERVICAL SPINE PLATES & TITANIUM BO..., manufactured by Acorn Group, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K914362 · Acorn Group, Inc. · Orthopedic device
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Apr 1992
Decision
211d
Days
Class 2
Risk

K914362 is an FDA 510(k) clearance for the TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Acorn Group, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 211 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 Acorn Group, Inc. devices

FDA 510(k) Submission Details - K914362

510(k) Number K914362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date April 29, 1992
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
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 639
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K914362.
CROSSLINK AXIAL AND OFFSET PLATES
K923242 · Sofamor Danek Mfg., Inc. · May 1993
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
K923446 · Sofamor Danek Mfg., Inc. · Dec 1992
ANTERIOR CERVICAL PLATE SYSTEM
K922087 · Sofamor Danek Mfg., Inc. · Nov 1992
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