ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0


Device Classification Name

neurological stereotaxic instrument

510(k) Number K072899
Device Name ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pkwy.
center valley, 
PA 
18034

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

Correspodent Contact matthew m hull
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 10/11/2007
Decision Date 02/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No