Cleared Traditional

K143320 - Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (FDA 510(k) Clearance)

K143320 · Stryker Corp. · Neurology device

Apr 2015

Decision

155d

Days

Class 2

Risk

K143320 is an FDA 510(k) clearance for the Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on April 23, 2015, 155 days after receiving the submission on November 19, 2014.

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

Submission Details

510(k) Number	K143320 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 19, 2014
Decision Date	April 23, 2015
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF