MODIFICATION TO ESOP CO-CR FEMORAL HEADS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K023375
Device Name MODIFICATION TO ESOP CO-CR FEMORAL HEADS
Original Applicant
PRO-ACTIVE HEALTHCARE
815 connecticut ave. nw
suite 800
washington, 
DC 
20006

Original Contact andre weith
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 10/08/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No