Cleared Special

MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM

K141989 · Mako Surgical Corporation · Orthopedic

Nov 2014

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K141989 is an FDA 510(k) clearance for the MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on November 13, 2014, 114 days after receiving the submission on July 22, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K141989 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2014
Decision Date	November 13, 2014
Days to Decision	114 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.