Cleared Special

Brainlab Compatible K2M Navigation Instruments

K192911 · K2m, Inc. · Orthopedic

Nov 2019

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K192911 is an FDA 510(k) clearance for the Brainlab Compatible K2M Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on November 14, 2019, 30 days after receiving the submission on October 15, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K192911 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2019
Decision Date	November 14, 2019
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.