ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS


Device Classification Name

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

510(k) Number K111492
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
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 888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OOG  
Date Received 05/31/2011
Decision Date 10/13/2011
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