Cleared Traditional

K143540 - Stryker MIS Attachments and Cutting Accessories (FDA 510(k) Clearance)

K143540 · Stryker Corporation · Neurology device

May 2015

Decision

137d

Days

Class 2

Risk

K143540 is an FDA 510(k) clearance for the Stryker MIS 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 Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 1, 2015, 137 days after receiving the submission on December 15, 2014.

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

Submission Details

510(k) Number	K143540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 15, 2014
Decision Date	May 01, 2015
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF