Cleared Traditional

Stryker MIS and Footed Attachments

K191049 · Stryker Corporation · Neurology
Jun 2019
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K191049 is an FDA 510(k) clearance for the Stryker MIS and Footed Attachments, 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 review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K191049 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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