Cleared Traditional

K210377 - Stryker iBur hubs and cutting accessories (FDA 510(k) Clearance)

K210377 · Stryker Corporation · Neurology device

Jun 2021

Decision

141d

Days

Class 2

Risk

K210377 is an FDA 510(k) clearance for the Stryker iBur hubs 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 (Portage, US). The FDA issued a Cleared decision on June 30, 2021, 141 days after receiving the submission on February 9, 2021.

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

Submission Details

510(k) Number	K210377 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2021
Decision Date	June 30, 2021
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF