ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM


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

Correspodent Contact janice haselton
Regulation Number 882.4560
Classification Product Code
OLO  
Date Received 06/29/2011
Decision Date 11/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No