ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM


Device Classification Name

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

510(k) Number K121640
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
Applicant
MATERIALISE N.V.
15 technologielaan
leuven, 

BE

3001

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

BE

3001

Correspodent Contact alexandra razzhivina
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received 06/04/2012
Decision Date 12/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls