Cleared Traditional

PRIMADO2 TOTAL SURGICAL SYSTEM

K132264 · Nakanishi, Inc. · Neurology
Dec 2013
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K132264 is an FDA 510(k) clearance for the PRIMADO2 TOTAL SURGICAL SYSTEM, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on December 17, 2013, 148 days after receiving the submission on July 22, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K132264 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2013
Decision Date December 17, 2013
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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