TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K072857
Device Name TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
Applicant
MEDACTA INTERNATIONAL, SA
18 birdie lane
norfolk, 
MA 
02056

Applicant Contact pamela j weagraff
Correspondent
MEDACTA INTERNATIONAL, SA
18 birdie lane
norfolk, 
MA 
02056

Correspodent Contact pamela j weagraff
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 10/05/2007
Decision Date 02/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls