SIGNATURE PLANNER,SIGNATURE GUIDES


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K111863
Device Name SIGNATURE PLANNER,SIGNATURE GUIDES
Applicant
MATERIALISE N.V.
15 technologielaan
leuven, 

BE

3001

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

BE

3001

Correspodent Contact alaxandra razzhivina
Regulation Number 888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   KWZ   LPH   LZO   MAY  
MEH  
Date Received 06/30/2011
Decision Date 06/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No