Cleared Traditional

K920256 - SPINE MOTION ANALYZER WITH EMG
(FDA 510(k) Clearance)

K920256 · Orthopedic Systems, Inc. · Neurology device

Aug 1992

Decision

202d

Days

Class 1

Risk

K920256 is an FDA 510(k) clearance for the SPINE MOTION ANALYZER WITH EMG. This device is classified as a Goniometer, Ac-powered (Class I - General Controls, product code KQX).

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on August 10, 1992, 202 days after receiving the submission on January 21, 1992.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K920256 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 21, 1992
Decision Date	August 10, 1992
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement