Cleared Traditional

K970713 - COMPASS UNIVERSAL HINGE (FDA 510(k) Clearance)

K970713 · Smith & Nephew, Inc., Orthopaedic Div. · Orthopedic device

Apr 1997

Decision

35d

Days

Class 2

Risk

K970713 is an FDA 510(k) clearance for the COMPASS UNIVERSAL HINGE. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Smith & Nephew, Inc., Orthopaedic Div. (Memphis, US). The FDA issued a Cleared decision on April 3, 1997, 35 days after receiving the submission on February 27, 1997.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K970713 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 27, 1997
Decision Date	April 03, 1997
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF