APEX PS KNEE SYSTEM – PS-C INSERT


Device Classification Name

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

510(k) Number K111184
Device Name APEX PS KNEE SYSTEM – PS-C INSERT
Applicant
OMNILIFE SCIENCE INC.
50 o’connell way
east taunton, 
MA 
02718

Applicant Contact radhika pondicherry
Correspondent
OMNILIFE SCIENCE INC.
50 o’connell way
east taunton, 
MA 
02718

Correspodent Contact radhika pondicherry
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received 04/27/2011
Decision Date 06/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No