SIGNATURE PLANNER / SIGNATURE GUIDES


Device Classification Name

prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer

510(k) Number K110415
Device Name SIGNATURE PLANNER / SIGNATURE GUIDES
Applicant
MATERIALISE N.V.
15 technologielaan
leuven, 

BE

3001

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

BE

3001

Correspodent Contact alexandra razzhivana
Regulation Number 888.3530
Classification Product Code
HRY  
Subsequent Product Codes
JWH   MBH   OIY   OOG  
Date Received 02/14/2011
Decision Date 05/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls