DIGIMATCH ROBODOC SURGICAL SYSTEM


Device Classification Name

orthopedic computer controlled surgical system

510(k) Number K072629
Device Name DIGIMATCH ROBODOC SURGICAL SYSTEM
Applicant
INTEGRATED SURGICAL SYSTEMS, INC.
1433 n. market blvd., #1
sacremento, 
CA 
95834

Applicant Contact russ hibbert
Correspondent
INTEGRATED SURGICAL SYSTEMS, INC.
1433 n. market blvd., #1
sacremento, 
CA 
95834

Correspodent Contact russ hibbert
Regulation Number 882.4560
Classification Product Code
OJP  
Subsequent Product Code
HAW  
Date Received 09/17/2007
Decision Date 08/06/2008
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