ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106


Device Classification Name

neurological stereotaxic instrument

510(k) Number K080547
Device Name ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact matthew m hull
Correspondent
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact matthew m hull
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 02/28/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No