Cleared Traditional

OLYMPIC Navigated Instruments

K172166 · Astura Medical · Orthopedic

Apr 2018

Decision

283d

Days

Class 2

Risk

About This 510(k) Submission

K172166 is an FDA 510(k) clearance for the OLYMPIC Navigated Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on April 27, 2018, 283 days after receiving the submission on July 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K172166 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2017
Decision Date	April 27, 2018
Days to Decision	283 days
Submission Type	Traditional
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.