Cleared Traditional

MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0

K081867 · Mako Surgical Corp. · Neurology
Nov 2008
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K081867 is an FDA 510(k) clearance for the MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on November 25, 2008, 147 days after receiving the submission on July 1, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K081867 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2008
Decision Date November 25, 2008
Days to Decision 147 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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