SURGICASE CONNECT, SURGICASE GUIDE


Device Classification Name

orthopaedic surgical planning and instrument guides

510(k) Number K112389
Device Name SURGICASE CONNECT, SURGICASE GUIDE
Applicant
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Applicant Contact alexandra razzhivina
Correspondent
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Correspodent Contact alexandra razzhivina
Regulation Number 888.3030
Classification Product Code
PBF  
Date Received 08/18/2011
Decision Date 07/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No