Cleared Traditional

K970751 - HEIDELBERG EXTERNAL FIXATOR (FDA 510(k) Clearance)

K970751 · Smith & Nephew, Inc., Orthopaedic Div. · Orthopedic device

Apr 1997

Decision

44d

Days

Class 2

Risk

K970751 is an FDA 510(k) clearance for the HEIDELBERG EXTERNAL FIXATOR. 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 16, 1997, 44 days after receiving the submission on March 3, 1997.

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

Submission Details

510(k) Number	K970751 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 1997
Decision Date	April 16, 1997
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF