Cleared Traditional

K962377 - 3D-SPINE

K962377 is an FDA 510(k) clearance for 3D-SPINE, manufactured by Skill Technologies, Inc.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K962377 · Skill Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
75d
Days
Class 1
Risk

K962377 is an FDA 510(k) clearance for the 3D-SPINE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Skill Technologies, Inc. (Phoenix, US). The FDA issued a Cleared decision on September 3, 1996 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Skill Technologies, Inc. devices

FDA 510(k) Submission Details - K962377

510(k) Number K962377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date September 03, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 148d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQX Goniometer, Ac-powered

All 9
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K962377.
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K971079 · Interlogics, Inc. · Jul 1997
SPINAL TOUCH
K961212 · Fasstech · Jun 1996
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
K940812 · Andronic Devices, Ltd. · Nov 1994
SPINE MOTION ANALYZER WITH EMG
K920256 · Orthopedic Systems, Inc. · Aug 1992
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
K897178 · Dynatronics Corp. · Apr 1990
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · Orthopedic Systems, Inc. · Jan 1990