Cleared Special

MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

K121064 · Mako Surgical Corporation · Orthopedic

Jun 2012

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K121064 is an FDA 510(k) clearance for the MAKOPLASTY TOTAL HIP APPLICATION, 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 June 6, 2012, 61 days after receiving the submission on April 6, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K121064 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2012
Decision Date	June 06, 2012
Days to Decision	61 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.