ORTHOPILOT HTO MODULE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K021327
Device Name ORTHOPILOT HTO MODULE
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Original Contact george keller
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 04/26/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No