Cleared Traditional

K983906 - DEPUY ORTHOTECH SPIKED WASHER (FDA 510(k) Clearance)

K983906 · DePuy Orthopaedics, Inc. · Orthopedic device

Dec 1998

Decision

45d

Days

Class 2

Risk

K983906 is an FDA 510(k) clearance for the DEPUY ORTHOTECH SPIKED WASHER. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 18, 1998, 45 days after receiving the submission on November 3, 1998.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K983906 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 1998
Decision Date	December 18, 1998
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF