APEX KNEE SYSTEM, APEX ALL POLY TIBIA


Device Classification Name

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

510(k) Number K111062
Device Name APEX KNEE SYSTEM, APEX ALL POLY TIBIA
Applicant
OMNILIFE SCIENCE INC.
50 o’connell way
suite #10
east taunton, 
MA 
02718

Applicant Contact christine nassif
Correspondent
OMNILIFE SCIENCE INC.
50 o’connell way
suite #10
east taunton, 
MA 
02718

Correspodent Contact christine nassif
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 04/18/2011
Decision Date 07/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No