MODIFICATION TO: APEX KNEE SYSTEM


Device Classification Name

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

510(k) Number K073602
Device Name MODIFICATION TO: APEX KNEE SYSTEM
Applicant
OMNLIFE SCIENCE
175 paramount drive
raynham, 
MA 
02767

Applicant Contact william mccallum
Correspondent
OMNLIFE SCIENCE
175 paramount drive
raynham, 
MA 
02767

Correspodent Contact william mccallum
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received 12/21/2007
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No