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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K111843
Device Name ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
Applicant
Smith & Nephew Inc., Endoscopy Div.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
Smith & Nephew Inc., Endoscopy Div.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact JANICE HASELTON
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/29/2011
Decision Date 11/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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