Cleared Traditional

ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

K111843 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic

Nov 2011

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K111843 is an FDA 510(k) clearance for the ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on November 14, 2011, 138 days after receiving the submission on June 29, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K111843 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2011
Decision Date	November 14, 2011
Days to Decision	138 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.