APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]


Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K080842
Device Name APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
Applicant
OMNI LIFE SCIENCE, INC.
175 paramount drive
raynham, 
MA 
02767

Applicant Contact william mccallum
Correspondent
OMNI LIFE SCIENCE, INC.
175 paramount drive
raynham, 
MA 
02767

Correspodent Contact william mccallum
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received 03/25/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No