Cleared Traditional

K191049 - Stryker MIS and Footed Attachments (FDA 510(k) Clearance)

K191049 · Stryker Corporation · Neurology device

Jun 2019

Decision

60d

Days

Class 2

Risk

K191049 is an FDA 510(k) clearance for the Stryker MIS and Footed Attachments. 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 June 18, 2019, 60 days after receiving the submission on April 19, 2019.

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

Submission Details

510(k) Number	K191049 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 19, 2019
Decision Date	June 18, 2019
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF