Cleared Traditional

K143399 - Stryker Footed Attachments and Cutting Accessories (FDA 510(k) Clearance)

K143399 · Stryker Corp. · Neurology device

May 2015

Decision

161d

Days

Class 2

Risk

K143399 is an FDA 510(k) clearance for the Stryker Footed Attachments and Cutting Accessories. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on May 8, 2015, 161 days after receiving the submission on November 28, 2014.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K143399 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 28, 2014
Decision Date	May 08, 2015
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF