Cleared Traditional

Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

K143320 · Stryker Corp. · Neurology
Apr 2015
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K143320 is an FDA 510(k) clearance for the Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments, 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 review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K143320 FDA.gov
FDA Decision Cleared 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

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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