Cleared Traditional

3D-SPINE

K962377 · Skill Technologies, Inc. · Neurology

Sep 1996

Decision

75d

Days

Class 1

Risk

About This 510(k) Submission

K962377 is an FDA 510(k) clearance for the 3D-SPINE, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Skill Technologies, Inc. (Phoenix, US). The FDA issued a Cleared decision on September 3, 1996, 75 days after receiving the submission on June 20, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K962377 FDA.gov
FDA Decision	Cleared 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